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OsteoMed 316-0211

by Osteomed Corp.

Ref 316-0211

OsteoMed 316-0211 is a device classified as Class IIa in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00845694035927) and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 00845694035927), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00845694035927 Basic UDI-DI 00845694035927UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694035927 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00845694035927 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00845694035927 listed 17 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694035927
  2. Registered EUDAMED B-00845694035927

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  • Withdrawn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
Acumed EUDAMED
OsteoMed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Device name
Instrument
Model / Ref / Catalog
316-0211
Primary DI / UDI-DI
00845694035927
Basic UDI-DI
B-00845694035927
FDA product code
HWC
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)