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Acumed 80-2354

by Acumed LLC

Part of a family of 13 devices: see the family page

Ref 80-2354Model Tray

Acumed 80-2354 is a Class I device made by Acumed LLC, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 0806378BUDI47QC) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378096433), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDI47QC Basic UDI-DI 10806378096433UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378096433 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDI47QC registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378096433 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378096433
  2. Registered EUDAMED 0806378BUDI47QC

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  • Withdrawn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
Device name
Polarus 3 Tray Base
Model / reference
80-2354, Tray
Primary DI / UDI-DI
10806378096433
Basic UDI-DI
0806378BUDI47QC
FDA product code
FSM
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I
Regulation number
878.4800
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 AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - 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)