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Acumed 80-1553

by Acumed LLC

Ref 80-1553Model Broach

Acumed 80-1553 is a Class I device made by Acumed LLC, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 0806378BUDI42Q2) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378049774), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDI42Q2 Basic UDI-DI 10806378049774UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378049774 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDI42Q2 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378049774 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378049774
  2. Registered EUDAMED 0806378BUDI42Q2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Polarus 3 EUDAMED
Acumed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / reference
80-1553, Broach
Primary DI / UDI-DI
10806378049774
Basic UDI-DI
0806378BUDI42Q2
FDA product code
LXH
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

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)