FDA Registration
Active
🇺🇸 United States
AmoCura Scar CuraScar Silicones
Reg #: 3005855077
·
FEI: 3005855077
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Amoena USA Corporation
- Registration Number
- 3005855077
- FEI Number
- 3005855077
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1000 Cobb Place Blvd. Ste. 200
- City
- Kennesaw
- State
- GA
- ZIP
- 30144
- Country
- US
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
- Correspondent
- ANDREAS - LINKE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2020-11-16 |
Proprietary Names
AmoCura Scar CuraScar Silicones
Establishment Types
Complaint File Establishment per 21 CFR 820.198