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COMPOGUARD Advance Basic 9029741

by Fresenius Kabi

Ref 9029741

COMPOGUARD Advance Basic 9029741 is a device classified as Class IIa in the EU and Class I in the US made by Fresenius Kabi, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 081002044CompoGuardSR) and listed in FDA GUDID since 30 Oct 2024 (UDI-DI 04086000860888), 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 Number081002044CompoGuardSR Basic UDI-DI 04086000860888UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04086000860888 UDI-DI Date30 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081002044CompoGuardSR registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 04086000860888 listed 30 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04086000860888
  2. Registered EUDAMED 081002044CompoGuardSR

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  • Withdrawn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
Compoguard Advance EUDAMED
COMPOGUARD Advance Basic GUDID
Generic name
Blood donation rocker
Model / Ref / Catalog
9029741
Primary DI / UDI-DI
04086000860888
Basic UDI-DI
081002044CompoGuardSR
FDA product code
KSQ
EMDN code
Z121780 Blood transfusion instruments - hardware accessories
GMDN term
Blood donation rocker
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
864.9195
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Blood donation rocker

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS.

Other devices from Fresenius Kabi

See all devices from Fresenius Kabi →

Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)