FDA U.S. Agent for medical device establishments in Germany
A medical device establishment in Germany that exports to the United States must register with FDA and name a U.S. Agent located in the U.S. (21 CFR 807.40). In the 12 months from 2025-10 to 2026-09, FDA refused 512 import lines from Germany, and 35 FDA import alerts list firms from Germany.
FDA data for Germany
Figures from FDA public data, retrieved 2026-10-21. Recall counts are by the recalling firm's country.
Import refusals, 2025-10 to 2026-09
| Refused import lines | 512 |
| Refusals citing registration or listing problems | NOT LISTED-118 · 218 FRNMFGREG-3280 · 136 REGISTERED-341 · 52 |
Most refused product industries
| Code | Count | |
|---|---|---|
| 79 | General & Plastic Surgery | 50 |
| 76 | Dental | 43 |
Most common refusal charges
| Code | Count |
|---|---|
| NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information… | 218 |
| UNAPPROVED-75 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). | 184 |
| FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i… | 136 |
| REGISTERED-341 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears the device is subject to listing under 510(j) and the initial distributor has not regis… | 52 |
| NO 510(K)-508 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantial… | 49 |
Import alerts listing Germany firms
Import alerts that list at least one firm in Germany: 35. Recently updated:
- Import Alert 89-04: Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements
Recalls by Germany firms, last 5 years
211 (Class II: 201, Class I: 7, Class III: 3)
Recent recall reasons:
- 2026-10 Potential for monomer liquid leakage.
- 2026-09 Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a re…
- 2026-09 The packaging may not consistently maintain sterile barrier integrity.
What the rule requires
Every foreign establishment that manufactures, prepares, propagates, compounds or processes a medical device imported into the United States must register with FDA, list its devices, and designate a single U.S. Agent. Registration is renewed every year between October 1 and December 31, and FDA's annual establishment fee must be paid first.
- Foreign manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers, relabelers and some kit assemblers of devices exported to the U.S.
- Initial importers in the U.S. register separately; they do not need a U.S. Agent
Deadlines
- Register within 30 days of beginning an operation that requires registration
- Renew annually between October 1 and December 31 (21 CFR 807.22)
- Pay the annual establishment registration user fee before submitting
Steps
- Pay FDA's annual establishment registration fee through the Device Facility User Fee website and get a Payment Identification Number
- Create an account in FDA's FURLS Device Registration and Listing Module (DRLM)
- Your official correspondent enters the establishment, owner/operator, U.S. Agent and device listings
- FDA emails the U.S. Agent to confirm the designation
- Keep your FEI and owner/operator number on file
Common mistakes
- Paying the user fee but never completing the registration in DRLM
- Naming a U.S. Agent who has not agreed. The agent must confirm in FDA's system
- Forgetting to list each device under the correct product code
- Believing that registration means FDA has cleared or approved the device. It does not
How US Agent Desk helps
We serve as your U.S. Agent, prepare the registration data in your language for your company's officer to submit, confirm the designation when FDA asks, and check FDA's public records for your company every morning. Prices start at $990 per year.
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Independent private service. Not affiliated with the U.S. FDA. Not legal advice.