Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010242262

FEI Number

3010242262

Entity Name

KONINKLIJKE (ROYAL) UTERMOHLEN N.V.

City/State/Country

Wolvega Fryslan, NL

Establishment Address

De Overweg 1, Wolvega Fryslan 8471ZA, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Koninklijke (Royal) Utermohlen NV (Owner Number: 10043448)

Owner / Operator Contact Address

De Overweg 1, Wolvega, NL-FR 8471ZA, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101049

PMA Number

N/A

All Registered Proprietary Names

UTERMOHLEN CRYO PROFESSIONAL WART FREEZE

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	2015-11-28
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2013-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

Gloria Ferko Business: Gloria Ferko LLC Email: gmferko@ptd.net Phone: (610) 7515823

Related Public Records

Same Entity

Koninklijke (Royal) Utermohlen 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
2124215	Boston Scientific Corporation	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010242262. Last updated year: 2026. Please use registration number 3010242262 when referencing this establishment in official correspondence.