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Acumed 80-0614

by Acumed LLC

Ref 80-0614

Acumed 80-0614 is a device classified as Class IIa in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-10806378043451) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378043451), 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-10806378043451 Basic UDI-DI 10806378043451UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378043451 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378043451 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 10806378043451 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378043451
  2. Registered EUDAMED B-10806378043451

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  • Withdrawn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
Generic name
General internal orthopaedic fixation system implantation kit
Device name
Instrument
Model / reference
80-0614
Primary DI / UDI-DI
10806378043451
Basic UDI-DI
B-10806378043451
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 Acumed LLC

See all devices from Acumed LLC →

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)