Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000194445

FEI Number

1000194445

Entity Name

CAM BIOCERAMICS

City/State/Country

LEIDEN Zuid-Holland, NL

Establishment Address

ZERNIKEDREEF 6, LEIDEN Zuid-Holland 2333 CL, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cam Bioceramics (Owner Number: 9041254)

Owner / Operator Contact Address

Zernikedreef 6, Leiden, NL-NOTA 2333 CL, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2021-06-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-12-31
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-31

Official Correspondent

Charlene Danoux

US Agent Details

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

Related Public Records

Same Entity

Cam Bioceramics

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
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000194445. Last updated year: 2026. Please use registration number 1000194445 when referencing this establishment in official correspondence.