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Acumed 70-0064

by Acumed LLC

Ref 70-0064

Acumed 70-0064 is a device classified as Class IIb in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-10806378032530) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378032530), 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-10806378032530 Basic UDI-DI 10806378032530UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378032530 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378032530 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378032530 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378032530
  2. Registered EUDAMED B-10806378032530

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  • Withdrawn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
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Device name
Plate
Model / reference
70-0064
Primary DI / UDI-DI
10806378032530
Basic UDI-DI
B-10806378032530
FDA product code
HRS
EMDN code
P09120502 Osteosynthesis neutralisation and support plates
GMDN term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, 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

Truth per registry

2 sources · 2 fields differ

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

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: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)