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Na 210-050-0101

by Biedermann Motech GmbH & Co. KG

Ref 210-050-0101Model Surgical Instruments

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

CE MDR

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 24 Oct 2026. What this means

Overview

A comprehensive medical device directory, with a detailed X-Ray Template device that offers a General internal orthopaedic fixation system implantation kit. This reusable device is intended for the placement of any type of internal orthopedic fixation system, including retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors. The device has been labeled as an OTC and is exempt from PM exemptions.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42508696000010019G Basic UDI-DI 04250869683920UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250869683920 UDI-DI Date7 Sep 2021ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
210-050-0101, Surgical Instruments
Primary DI / UDI-DI
04250869683920
Basic UDI-DI
42508696000010019G
FDA Product Code
LXH
EMDN Code
L091099 Osteosynthesis instruments, reusable - other
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class I
Regulation Number
888.4540
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
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No