FDA Registration
Active
🇩🇪 Germany
AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
Reg #: 1000641183
·
FEI: 1000641183
·
Expires 2026
Products
7
Proprietary Names
4
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
- Registration Number
- 1000641183
- FEI Number
- 1000641183
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KAPELLENWEG 36
- City
- RAUBLING, BAVARIA
- Country
- DE
Owner / Operator
- Firm Name
- AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
- Operator Number
- 9105040
- Address
- KAPELLENWEG 36, --
- City
- RAUBLING, BAVARIA
- State
- DE-NOTA
- Postal Code
- D-83064
- Country
- DE
US Agent
- Business Name
- Amoena USA Corporation
- Contact Name
- Taimur Mehmood
- Address
- 1000 Cobb Place Blvd. Ste. 200
- City
- Kennesaw
- State
- GA
- ZIP
- 30144
- Country
- US
- [email protected]
- Phone
- 770 2818230
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Breast, External, No Adhesive | NOJ | Class 1 | General, Plastic Surgery | No | 2011-01-19 |
| Prosthesis, Adhesive, External | GBJ | Class 1 | General, Plastic Surgery | No | 2002-09-06 |
| Prosthesis, Breast, External, Used With Adhesive | KCZ | Class 1 | General, Plastic Surgery | No | 2001-08-14 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2020-11-16 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2011-02-16 |
| Binder, Elastic | KMO | Class 1 | General Hospital | No | 2012-01-09 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2012-03-08 |
Proprietary Names
Amoena PurFit
Amoena
AmoCura Scar CuraScar Silicones
Amovida
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility