Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004753330

FEI Number

3004753330

Entity Name

H&O EQUIPMENTS NV/Clinic6

City/State/Country

Ghislenghien Hainaut, BE

Establishment Address

Rue des Journaliers 1, Ghislenghien Hainaut 7822, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

H&O Equipments NV/Clinic6 (Owner Number: 10027912)

Owner / Operator Contact Address

Rue des Journaliers, 1, Ghislenghien, BE-NOTA 7822, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161615

PMA Number

N/A

All Registered Proprietary Names

CryoProbe o Freezpen CryoPen c CryoProbe C CryoProbe X CryoProbe m CryoProbe CryoProbe Touch N2O Cartridges CryoProbe b CryoProbe XP CryoProbe X+ CryoProbe B+ Freezpen 16g CryoProbe O+ CryoProbe M Freezpen 35g Freezpen 8g CryroProbe XPS Accurett CO2 cartridges

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	2008-12-15
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2016-08-30

Official Correspondent

Mindy McCann

US Agent Details

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

Related Public Records

Same Entity

H&O Equipments NV/Clinic6

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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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 3004753330. Last updated year: 2026. Please use registration number 3004753330 when referencing this establishment in official correspondence.