Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014144368

FEI Number

3014144368

Entity Name

OPTIMAT (AFDELING HUIZE TORDALE VZW)

City/State/Country

Lichtervelde West-Vlaanderen, BE

Establishment Address

Kortemarkstraat 86, Lichtervelde West-Vlaanderen 8810, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OptimaT (Afdeling Huize Tordale vzw) (Owner Number: 10056214)

Owner / Operator Contact Address

Kortemarkstraat 86, Lichtervelde, BE-VWV 8810, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compound W Nitrofreeze

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

Official Correspondent

Hein Moerman

US Agent Details

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

Related Public Records

Same Entity

OptimaT (Afdeling Huize Tordale vzw)

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 3014144368. Last updated year: 2026. Please use registration number 3014144368 when referencing this establishment in official correspondence.