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Acumed Hr-5135

by Acumed LLC

Ref 30-0780

Acumed Hr-5135 is a device classified as Class IIa in the EU and Class I in the US made by Acumed LLC, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-10806378069697) and listed in FDA GUDID since 18 Jan 2019 (UDI-DI 10806378069697), 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-10806378069697 Basic UDI-DI 10806378069697UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378069697 UDI-DI Date18 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378069697 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378069697 listed 18 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378069697
  2. Registered EUDAMED B-10806378069697

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  • Withdrawn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
Driver
Model / reference
30-0780 EUDAMED
HR-5135 GUDID
Primary DI / UDI-DI
10806378069697
Basic UDI-DI
B-10806378069697
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa 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
Model / referenceEUDAMED
30-0780
GUDID
HR-5135
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa 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 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)