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OsteoMed 213-1611

by Osteomed Corp.

Ref 213-1611

OsteoMed 213-1611 is a device classified as Class IIb in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00845694033800) and listed in FDA GUDID since 8 Apr 2015 (UDI-DI 00845694033800), 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-00845694033800 Basic UDI-DI 00845694033800UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694033800 UDI-DI Date8 Apr 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00845694033800 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00845694033800 listed 8 Apr 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694033800
  2. Registered EUDAMED B-00845694033800

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  • Withdrawn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
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device name
Plate
Model / Ref / Catalog
213-1611
Primary DI / UDI-DI
00845694033800
Basic UDI-DI
B-00845694033800
FDA product code
DZL
EMDN code
P09120502 Osteosynthesis neutralisation and support plates
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4880
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
Size
Length — 107 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Craniofacial fixation plate, non-bioabsorbable, non-customized

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

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