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Na 207-060-0114

by Biedermann Motech GmbH & Co. KG

Ref 207-060-0114

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

CE MDR

Valid until

6 Dec 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000319811 Date7 Jul 2026IssuedStatusActive expires 6 Dec 2028
United StatesGUDID listing GUDID Number04250869634939 UDI-DI Date20 Nov 2018ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000319811 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    7 Jul 2026
    Expires
    6 Dec 2028
    Reason
    Add device or group

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
General internal orthopaedic fixation system implantation kit
Device Name
Surgical Instruments
Model / Ref / Catalog
207-060-0114
Primary DI / UDI-DI
04250869634939
Basic UDI-DI
42508696000010029J
FDA Product Code
GAD
EMDN Code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: General internal orthopaedic fixation system implantation kit

Other devices from Biedermann Motech GmbH & Co. KG

See all devices from Biedermann Motech GmbH & Co. KG →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No