[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-trans-missie-bv-720852-12162025":3,"fda-latest-sync-dates":28},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":11,"response_letter_date":8,"closeout_date":8,"case_status":12,"letter_url":13,"reference_number":8,"marcs_cms_no":14,"product_type":15,"delivery_method":16,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},410,"trans-missie-bv-720852-12162025","Warning Letter","Trans-Missie B.V.",null,"Center for Devices and Radiological Health","Failure to Register and List\u002FMisbranded","2025-12-16","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ftrans-missie-bv-720852-12162025","720852","Medical Devices","VIA Electronic Mail","Danaë Kurvers","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Danaë Kurvers\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Trans-Missie B.V.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Visseringweg 3A\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"postal-code\">1112AS\u003C\u002Fspan> \u003Cspan class=\"locality\">Diemen\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Netherlands\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:abuse@untag.com\"> abuse@untag.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Devices and Radiological Health\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\n    \n     \n        \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n    \n    \n    \n    \n\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>\u003Cstrong>CMS #720852\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>December 16, 2025\u003C\u002Fp>\u003Cp>\u003Cbr>Dear Danaë Kurvers:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) has reviewed Trans-Missie B.V. d\u002Fb\u002Fa UNTAG’s (“your firm”) website (untag.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\u003C\u002Fp>\u003Cp>Our review of your firm’s website revealed statements that these breast binders (example trade names: “Short Binder black”, “Short Binder – Extra Strong black”, “Gym Binder – Extra strong black”, “Short Binder beige”, “Short Binder – Extra Strong Beige”, “Tank Binder”, “Shirt Binder beige”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:\u003C\u002Fp>\u003Cp>•    Per your firm’s website: “A binder works by pressing the breasts flat against the chest, spreading the mass of the breasts. This makes the breasts appear flatter and less present, which can help reduce gender dysphoria or any other uncomfortable feelings that you might have about your chest.”\u003Cbr>•    Per your firm’s website: “Most people wear a binder because it helps reduce any gender dysphoria that they experience about their breasts. Binders can be worn by … people who have just had breast surgery, people who suffer from gender dysphoria.”\u003Cbr>•    Per your firm’s website: “A binder can greatly help to reduce body dysphoria and promote gender euphoria”\u003Cbr>•    Per your firm’s website: “Reduced dysphoria: Binding alleviates the distress associated with a chest that does not align with one’s gender identity…Improved mental health: Participants in multiple studies reported reduced anxiety and depression, increased confidence, and greater comfort in public spaces”\u003Cbr>•    Per your firm’s website: “Gender affirming garments can help you alleviate gender dysphoria by compressing or enhancing body parts that cause you negative feelings. As you can imagine, some of these gender affirming practices (like wearing binders) are not entirely without risk.”\u003C\u002Fp>\u003Cp>Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “UNTAG products are designed and engineered in Diemen - Amsterdam.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA.  In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year.  Our records indicate that you have not registered or listed these devices for fiscal year 2026.\u003C\u002Fp>\u003Cp>Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).\u003C\u002Fp>\u003Cp>Your firm should take prompt action to address any violations identified in this letter.  Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure and injunction.  \u003C\u002Fp>\u003Cp>Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.\u003C\u002Fp>\u003Cp>Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and\u002For corrective action (which must address systemic problems) that your firm has taken.  If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Please provide a translation of documentation not in English to facilitate our review.  We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and\u002For corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.\u003C\u002Fp>\u003Cp>Your firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720852” when replying.\u003C\u002Fp>\u003Cp>Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.  \u003C\u002Fp>\u003Cp>Sincerely yours,\u003Cbr>\u002Fs\u002F\u003Cbr>Michael J. Hoffmann\u003Cbr>Director\u003Cbr>Office of Health Technology 3 - Gastrorenal, ObGyn,\u003Cbr>General Hospital, and Urology Devices\u003Cbr>Office of Product Evaluation and Quality\u003Cbr>Center for Devices and Radiological Health\u003Cbr>Food and Drug Administration\u003C\u002Fp>\u003Cp>\u003Cbr>cc: Shopify, Inc.\u003Cbr>abuse@shopify.com\u003C\u002Fp>\u003Cp>cc: service@untag.com\u003Cbr> \u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA Electronic Mail\n\nProduct:\n\nMedical Devices\n\nRecipient:\n\nRecipient Name\n\nDanaë Kurvers\n\nRecipient Title\n\nOwner\n\nTrans-Missie B.V.\n\nVisseringweg 3A\n\n1112AS Diemen\n\nNetherlands\n\nabuse@untag.com\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWARNING LETTER\nCMS #720852\nDecember 16, 2025\n\nDear Danaë Kurvers:\nThe United States Food and Drug Administration (FDA) has reviewed Trans-Missie B.V. d\u002Fb\u002Fa UNTAG’s (“your firm”) website (untag.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\nOur review of your firm’s website revealed statements that these breast binders (example trade names: “Short Binder black”, “Short Binder – Extra Strong black”, “Gym Binder – Extra strong black”, “Short Binder beige”, “Short Binder – Extra Strong Beige”, “Tank Binder”, “Shirt Binder beige”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:\n• Per your firm’s website: “A binder works by pressing the breasts flat against the chest, spreading the mass of the breasts. This makes the breasts appear flatter and less present, which can help reduce gender dysphoria or any other uncomfortable feelings that you might have about your chest.”\n• Per your firm’s website: “Most people wear a binder because it helps reduce any gender dysphoria that they experience about their breasts. Binders can be worn by … people who have just had breast surgery, people who suffer from gender dysphoria.”\n• Per your firm’s website: “A binder can greatly help to reduce body dysphoria and promote gender euphoria”\n• Per your firm’s website: “Reduced dysphoria: Binding alleviates the distress associated with a chest that does not align with one’s gender identity…Improved mental health: Participants in multiple studies reported reduced anxiety and depression, increased confidence, and greater comfort in public spaces”\n• Per your firm’s website: “Gender affirming garments can help you alleviate gender dysphoria by compressing or enhancing body parts that cause you negative feelings. As you can imagine, some of these gender affirming practices (like wearing binders) are not entirely without risk.”\nOur review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “UNTAG products are designed and engineered in Diemen - Amsterdam.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.\nTherefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).\nYour firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and injunction.\nOther federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.\nPlease notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and\u002For corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.\nYour firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720852” when replying.\nFinally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.\nSincerely yours,\n\u002Fs\u002F\nMichael J. Hoffmann\nDirector\nOffice of Health Technology 3 - Gastrorenal, ObGyn,\nGeneral Hospital, and Urology Devices\nOffice of Product Evaluation and Quality\nCenter for Devices and Radiological Health\nFood and Drug Administration\n\ncc: Shopify, Inc.\nabuse@shopify.com\ncc: service@untag.com","2026-08-19T16:09:36.063+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2025-12-16T16:00:00Z\">12\u002F16\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-12-16T05:00:00Z\">12\u002F16\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ftrans-missie-bv-720852-12162025\">Trans-Missie B.V.\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]