FDA device listing
Amoena
FDA device listing 1650912873 · AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
Key facts
| Proprietary names | Amoena |
|---|---|
| Owner/operator | AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH |
| Owner/operator number | 9105040 |
| Product codes | KCZ |
| Device names | KCZ - Prosthesis, Breast, External, Used With Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.3800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH, Amoena USA Corporation |
| Establishment registrations | 1000641183, 3005855077 |
| FEI numbers | 1000641183, 3005855077 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database