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OsteoMed 320-5127

by Osteomed Corp.

Ref 320-5127

OsteoMed 320-5127 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-00845694093798) and listed in FDA GUDID since 9 Jun 2016 (UDI-DI 00845694093798), 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-00845694093798 Basic UDI-DI 00845694093798UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694093798 UDI-DI Date9 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00845694093798 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00845694093798 listed 9 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694093798
  2. Registered EUDAMED B-00845694093798

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  • Withdrawn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
Fluted surgical drill bit, single-use, non-sterile
Device name
Drill
Model / Ref / Catalog
320-5127
Primary DI / UDI-DI
00845694093798
Basic UDI-DI
B-00845694093798
FDA product code
HRS
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Fluted surgical drill bit, single-use, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
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 — 81 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: Fluted surgical drill bit, single-use, non-sterile

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING 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)