Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031563325

FEI Number

3031563325

Entity Name

HCM MEDICAL

City/State/Country

Nijmegen Gelderland, NL

Establishment Address

Kerkenbos 10-113, Nijmegen Gelderland 6546BJ, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HCM Medical (Owner Number: 10090942)

Owner / Operator Contact Address

Kerkenbos 10-113, Nijmegen, NL-GE 6546BJ, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biopad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-06-12
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2026-04-03

Official Correspondent

Joann Koster-van Essen

US Agent Details

Pamela Mccoll Email: pamela.mccoll@gmlx.us.com Phone: (678) 5021617

Related Public Records

Same Entity

HCM Medical

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
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29

Similar Registrations

Registration Number	Establishment Name	Location
3007738819	OSferionBiomaterials Corp. Mishima Factory	Sunto-gun Shizuoka, JP
3019403037	HERAEUS MEDICAL LLC - BIORESOBABLES	Yardley, PA, US
3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031563325. Last updated year: 2026. Please use registration number 3031563325 when referencing this establishment in official correspondence.