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Acumed Am-5010-S

by Acumed LLC

Ref AM-5010-S

Acumed Am-5010-S is a device classified as Class IIb in the EU and Class I in the US made by Acumed LLC, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-10806378055126) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378055126), 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-10806378055126 Basic UDI-DI 10806378055126UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378055126 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378055126 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378055126 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378055126
  2. Registered EUDAMED B-10806378055126

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  • Withdrawn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
Drill
Model / reference
AM-5010-S
Primary DI / UDI-DI
10806378055126
Basic UDI-DI
B-10806378055126
FDA product code
HTW
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I 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 PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)