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bioXEN OUSM1SEU

by Collagen Matrix, Inc.

Ref OUSM1SEU

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813954028170 Basic UDI-DI 00813954028170UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813954028170 UDI-DI Date6 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
bioXEN Bone Graft Particulate EUDAMED
bioXEN GUDID
Generic Name
Dental bone void filling material, animal-derived
Device Name
Anorganic Bovine Bone Mineral in Jar or Syringe
Model / Ref / Catalog
OUSM1SEU
Primary DI / UDI-DI
00813954028170
Basic UDI-DI
B-00813954028170
FDA Product Code
NPM
EMDN Code
Q010302 Dental graft devices
GMDN Term
Dental bone void filling material, animal-derived
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
872.3930
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Other devices from Collagen Matrix, Inc.

See all devices from Collagen Matrix, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Animal Tissues
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No