Data / Medical devices / Belgium / Oystershellnv
Oystershellnv: FDA-registered device maker in Merelbeke-Melle Oost-Vlaanderen, Belgium, 3 510(k) clearances
Oystershellnv is registered with the FDA (registration 3004416964) in Merelbeke-Melle Oost-Vlaanderen, Belgium. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 18, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004416964
- Address
- Nijverheidsweg 10, Merelbeke-Melle Oost-Vlaanderen, Belgium, 9820
- Owner or operator
- Oystershell NV (10056215)
- Roles
- Specification developer
- First device listed
- November 16, 2017
- Registered through
- 2027
- Brand names listed
- COMPOUND W NITROFREEZE, COMPOUND W NITROFREEZE 10ML + GELPADS, COMPOUND W NITROFREEZE FIRST AID, Compound W Nitro Freeze Skin Tag Remover, NIX ULTRA SHAMPOO, NIX ULTRA SHAMPOO FIRST AID, Nix Ultra Cream Rinse, RID SUPER MAX ADVANCED SHAMPOO and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detectors And Removers, Lice, (Including Combs) | LJL | 1 | Specification developer | accessdata.fda.gov |
| Lice Removal Kit Containing A Solution | PUN | 1 | Specification developer | accessdata.fda.gov |
| ORE | ORE | Specification developer | accessdata.fda.gov | |
| Unit, Cryosurgical, Accessories | GEH | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2024 | K240226 | Pixie Skin Tag | ORE | Substantially Equivalent | Oystershell NV | accessdata.fda.gov |
| November 2, 2017 | K172373 | Compound W Nitro-Freeze | GEH | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
| March 21, 2017 | K163401 | Nix Ultra Lice Treatment Kit | LJL | Substantially Equivalent | Medtech Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of Lice Removal Kit Containing A Solution
- All makers of Detectors And Removers, Lice, (Including Combs)
Updated October 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.