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OsteoMed 214-2025T

by Osteomed Corp.

Part of a family of 11 devices: see the family page

Ref 214-2025TModel TEMPLATES

OsteoMed 214-2025T is a device classified as Class IIa in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 0806378BUDIO63S4) and listed in FDA GUDID since 21 Jul 2016 (UDI-DI 00845694049320), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDIO63S4 Basic UDI-DI 00845694049320UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694049320 UDI-DI Date21 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDIO63S4 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 00845694049320 listed 21 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694049320
  2. Registered EUDAMED 0806378BUDIO63S4

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  • Withdrawn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

Trade name
Acumed EUDAMED
OsteoMed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
214-2025T, TEMPLATES
Primary DI / UDI-DI
00845694049320
Basic UDI-DI
0806378BUDIO63S4
FDA product code
DZL
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4880
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 134 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)