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Acumed DRB1115

by Acumed LLC

Ref DRB1115

Acumed DRB1115 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-10806378064289) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378064289), 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-10806378064289 Basic UDI-DI 10806378064289UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378064289 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378064289 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378064289 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378064289
  2. Registered EUDAMED B-10806378064289

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  • Withdrawn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
Orthopaedic fixation plate, non-bioabsorbable
Device name
Drill
Model / reference
DRB1115
Primary DI / UDI-DI
10806378064289
Basic UDI-DI
B-10806378064289
FDA product code
LXH
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

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

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: Orthopaedic fixation plate, non-bioabsorbable

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

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