FDA Registration
Active
🇧🇪 Belgium
OYSTERSHELLNV
Reg #: 3004416964
·
FEI: 3004416964
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- OYSTERSHELLNV
- Registration Number
- 3004416964
- FEI Number
- 3004416964
- Status
- Active
- Expiry Year
- 2026
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2017-11-16 |
| Detectors And Removers, Lice, (Including Combs) | LJL | Class 1 | General Hospital | No | 2020-10-28 |
| Lice Removal Kit Containing A Solution | PUN | Class 1 | General Hospital | No | 2025-03-25 |
| ORE | No | 2025-01-14 |
Proprietary Names
COMPOUND W NITROFREEZE 10ML + GELPADS
COMPOUND W NITROFREEZE
COMPOUND W NITROFREEZE FIRST AID
COMPOUND W NITROFREEZE + GELPADS
Nix Ultra Cream Rinse
RID SUPER MAX SOLUTION
Compound W Nitro Freeze Skin Tag Remover
RID SUPER MAX KIT
RID SUPER MAX SENSITIVE SKIN
RID SUPER MAX ADVANCED SHAMPOO
NIX ULTRA SHAMPOO
NIX ULTRA SHAMPOO FIRST AID
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility