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A-K-FIX Blutgasentnahmesystem steril, ~230 µl - 2, 33 x 131 mm, ~100 I.U./ml Lithium-Heparin (balanciert)

by SC - Sanguis Counting Kontrollblutherstellungs- und Vertriebs GmbH 3 variants

Ref 191220

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426015999106AU Basic UDI-DI 04260159990768UDI-DIDate27 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
A-K-FIX Blutgasentnahmesystem steril und Kapillar-Set steril
Model / Reference
191220
Primary DI / UDI-DI
04260159990768
Basic UDI-DI
426015999106AU
Direct Marketing DI
04260159990768
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000023385

From the manufacturer

Manufacturer's product page: A-K-FIX Blutgasentnahmesystem steril

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Properties

  • Sterile

Other properties (10)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No