FDA Registration
Active
🇧🇪 Belgium
COMPOUND W NITROFREEZE FIRST AID
Reg #: 3004416964
·
FEI: 3004416964
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OYSTERSHELLNV
- Registration Number
- 3004416964
- FEI Number
- 3004416964
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Nijverheidsweg 10
- City
- Merelbeke-Melle Oost-Vlaanderen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K172373
Owner / Operator
- Firm Name
- Oystershell NV
- Operator Number
- 10056215
- Address
- Nijverheidsweg 10
- City
- Merelbeke
- State
- Oost-Vlaanderen
- Postal Code
- 9820
- Country
- BE
- Correspondent
- Bart Rossel
US Agent
- Business Name
- FDAIMPORTS LLC
- Contact Name
- FDAIMPORTS.COM LLC
- Address
- 2631 Housley Road, #1211
- City
- Annapolis
- State
- MD
- ZIP
- 21401
- Country
- US
- [email protected]
- Phone
- 410 2202800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2017-11-16 |
Proprietary Names
COMPOUND W NITROFREEZE FIRST AID
COMPOUND W NITROFREEZE
COMPOUND W NITROFREEZE + GELPADS
COMPOUND W NITROFREEZE 10ML + GELPADS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility