Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004416964

FEI Number

3004416964

Entity Name

OYSTERSHELLNV

City/State/Country

Merelbeke-Melle Oost-Vlaanderen, BE

Establishment Address

Nijverheidsweg 10, Merelbeke-Melle Oost-Vlaanderen 9820, BE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Oystershell NV (Owner Number: 10056215)

Owner / Operator Contact Address

Nijverheidsweg 10, Merelbeke, BE-VOV 9820, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-11-16
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2020-10-28
PUN	Lice Removal Kit Containing A Solution	General Hospital	Class 1	880.5960	2025-03-25
ORE	N/A	N/A	Class N/A	N/A	2025-01-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-01-14
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2020-10-28

Official Correspondent

Bart Rossel

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

Oystershell NV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3004753330	H&O EQUIPMENTS NV/Clinic6	Ghislenghien Hainaut, BE
3010140265	CSA Medical	Lexington, MA, US
3012697079	COOL RENEWAL, LLC	Nashville, TN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3010242262	KONINKLIJKE (ROYAL) UTERMOHLEN N.V.	Wolvega Fryslan, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004416964. Last updated year: 2026. Please use registration number 3004416964 when referencing this establishment in official correspondence.