Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020164048

FEI Number

3020164048

Entity Name

THEOTCLAB HEALTHCARE B.V.

City/State/Country

Amsterdam Noord-Holland, NL

Establishment Address

Fred. Roeskestraat 115, Amsterdam Noord-Holland 1076 EE, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TheOTCLab Healthcare B.V. (Owner Number: 10082583)

Owner / Operator Contact Address

Fred. Roeskestraat 115, Amsterdam, NL-NH 1076EE, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251524

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2026-02-17

Official Correspondent

Albert Swane

US Agent Details

Mindy McCann Business: Qserve Group US Inc Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

TheOTCLab Healthcare B.V.

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

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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 3020164048. Last updated year: 2026. Please use registration number 3020164048 when referencing this establishment in official correspondence.