Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011307964

FEI Number

3011307964

Entity Name

YOUMEDICAL B.V.

City/State/Country

Amsterdam Noord-Holland, NL

Establishment Address

Barbara Strozzilaan 201, Amsterdam Noord-Holland 1083 HN, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

YouMedical B.V. (Owner Number: 10047783)

Owner / Operator Contact Address

Klara norra kyrkogata 33, Stockholm, Sweden, SE-AB 11122, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wartie Wart Remover and other proprietary name Wartie Wart Remover and proprietary name

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	2014-10-31
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2015-11-18

Official Correspondent

Helena Blomberg

US Agent Details

Vincent Argiro Email: vargiro@prestigebrands.com Phone: (914) 5248721

Related Public Records

Same Entity

YouMedical 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

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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 3011307964. Last updated year: 2026. Please use registration number 3011307964 when referencing this establishment in official correspondence.