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Sign in to claim this brandAMOENA Medizin-Orthopädie-Technik GmbH
US
Last updated May 30, 2026
What AMOENA Medizin-Orthopädie-Technik GmbH makes
AMOENA Medizin-Orthopädie-Technik GmbH manufactures external breast prostheses, nipple prostheses, and reusable scar-management dressings designed for post-mastectomy or surgical recovery support. Their products are tailored for patients requiring customised prosthetic solutions or skin protection during healing.
The company’s devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable medical device compliance standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AMOENA Medizin-Orthopädie-Technik GmbH manufacture?
AMOENA specialises in external medical devices primarily used for post-surgical recovery. Their portfolio includes external breast prostheses, nipple prostheses (external), and reusable scar-management dressings. These products are designed to support patients undergoing mastectomy or other surgeries requiring prosthetic or skin protection solutions during healing.
Where is AMOENA Medizin-Orthopädie-Technik GmbH based?
The company is based in the United States. While the exact location isn’t specified, its operations are governed by U.S. medical device regulations, including compliance with applicable standards for manufacturing and distribution.
Which regulatory registries list AMOENA’s devices?
AMOENA’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency for Class I devices, which are generally considered low-risk but still subject to regulatory oversight.
How are AMOENA’s devices classified under FDA regulations?
AMOENA’s devices fall under Class I classification in the FDA’s regulatory framework. This classification applies to products posing minimal risk to patients, such as external prostheses and scar-management dressings, which typically require general controls (e.g., good manufacturing practices) rather than stringent pre-market approval.
Why are AMOENA’s devices classified as Class I?
The FDA categorises devices based on risk and intended use. AMOENA’s external prostheses, nipple prostheses, and scar-management dressings are considered low-risk because they do not invade the body, do not support life-sustaining functions, and pose minimal harm even if misused. Class I devices undergo general controls (e.g., labeling, manufacturing standards) rather than pre-market review, as their risks are deemed manageable through routine oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- amoena.com
- —
- —
- [email protected]
- Phone
- 1 (888) 900-8998
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 312770613
Catalogue (235)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amoena | 334 Adapt Air Contact Light 2SN 10 | FDA UDI | Class I | Active |
| Amoena | 381 Contact 2S 03 | FDA UDI | Class I | Active |
| Amoena | 382 Contact 3S 03 | FDA UDI | Class I | Active |
| Amoena | 382T Contact 3S TW 04 | FDA UDI | Class I | Active |
| Amoena | 383 Contact 2A, 03 R | FDA UDI | Class I | Active |
| Amoena | 382TC Contact 3S TW, 01 | FDA UDI | Class I | Active |
| Amoena | 385 Contact light 3S, 03 | FDA UDI | Class I | Active |
| Amoena | 286 Balance Contact SV, M | FDA UDI | Class I | Active |
| Amoena | 383 Contact 2A, 10 L | FDA UDI | Class I | Active |
| Amoena | 382 Contact 3S 04 | FDA UDI | Class I | Active |
| Amoena | 382T Contact 3S TW 07 | FDA UDI | Class I | Active |
| Amoena | 382E Contact 3S EB, 05 | FDA UDI | Class I | Active |
| Amoena | 380 Contact light 2S 11 | FDA UDI | Class I | Active |
| Amoena | 386 Contact 3 E, 11 R | FDA UDI | Class I | Active |
| Amoena | 381 Contact 2S 08 | FDA UDI | Class I | Active |
| Amoena | 386T Contact 3 E, TW 12 L | FDA UDI | Class I | Active |
| Amoena | 383 Contact 2A, 04 R | FDA UDI | Class I | Active |
| Amoena | 386T Contact 3 E, TW 10 L | FDA UDI | Class I | Active |
| Amoena | 382 Contact 3S 07 | FDA UDI | Class I | Active |
| Amoena | 230 Balance Contact VD, 07/08 | FDA UDI | Class I | Active |
| Amoena | 384C Contact 1S, 05 | FDA UDI | Class I | Active |
| Amoena | 386T Contact 3 E, TW 01 L | FDA UDI | Class I | Active |
| Amoena | 384C Contact 1S, 08 | FDA UDI | Class I | Active |
| Amoena | 384C Contact 1S, 07 | FDA UDI | Class I | Active |
| Amoena | 382T Contact 3S TW, 07 | FDA UDI | Class I | Active |
| Amoena | 137 Nipple Set almond large | FDA UDI | Class I | Active |
| Amoena | 382E Contact 3S EB, 04 | FDA UDI | Class I | Active |
| Amoena | 334 Adapt Air Contact Light 2SN 05 | FDA UDI | Class I | Active |
| Amoena | 385 Contact light 3S, 08 | FDA UDI | Class I | Active |
| Amoena | 382T Contact 3S TW, 10 | FDA UDI | Class I | Active |
| Amoena | 384C Contact 1S, 11 | FDA UDI | Class I | Active |
| Amoena | 230T Balance Cont VD TW, 07/08 | FDA UDI | Class I | Active |
| Amoena | 382T Contact 3S TW, 02 | FDA UDI | Class I | Active |
| Amoena | 384C Contact 1S, 01 | FDA UDI | Class I | Active |
| Amoena | 386T Contact 3 E, TW 11 R | FDA UDI | Class I | Active |
| Amoena | 304 Custom +++ TW | FDA UDI | Class I | Active |
| Amoena | 286 Balance Contact SV, XL | FDA UDI | Class I | Active |
| Amoena | 382E Contact 3S EB, 09 | FDA UDI | Class I | Active |
| Amoena | 380 Contact light 2S 05 | FDA UDI | Class I | Active |
| Amoena | 381 Contact 2S 09 | FDA UDI | Class I | Active |
| Amoena | 386T Contact 3 E, TW 09 R | FDA UDI | Class I | Active |
| Amoena | 382E Contact 3S EB, 01 | FDA UDI | Class I | Active |
| Amoena | 381 Contact 2S 02 | FDA UDI | Class I | Active |
| Amoena | 382T Contact 3S TW 10 | FDA UDI | Class I | Active |
| Amoena | 334 Adapt Air Contact Light 2SN 01 | FDA UDI | Class I | Active |
| Amoena | 382 Contact 3S 01 | FDA UDI | Class I | Active |
| Amoena | 380 Contact light 2S 01 | FDA UDI | Class I | Active |
| Amoena | 382 Contact 3S 02 | FDA UDI | Class I | Active |
| Amoena | 382E Contact 3S EB, 02 | FDA UDI | Class I | Active |
| Amoena | 334 Adapt Air Contact Light 2SN 07 | FDA UDI | Class I | Active |
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