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Albumin

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref B21005, B30006, B24005, B22005, B27006, B28005, B45006, B21006Model Albumin 432 mL, ALBUMIN Kit 240mL, ALBUMIN Kit 150mL, Albumin 230 mL, ALBUMIN Kit 320mL, Albumin 240 mL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683555600103 Basic UDI-DIDate7 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
Albumin
Albumin Kit
Model / Reference
Albumin 432 mL, B21005, ALBUMIN Kit 240mL, B30006, ALBUMIN Kit 150mL, B24005, Albumin 230 mL, B22005, B27006, ALBUMIN Kit 320mL, B28005, B45006, Albumin 240 mL, B21006
Primary DI / UDI-DI
08683555600103, 08683555613899, 08683555613288, 08683555611857, 08683555611574, 08683555618399, 08683555622082, 08683555601001
Basic UDI-DI
B-08683555600103, B-08683555613899, B-08683555613288, B-08683555611857, B-08683555611574, B-08683555618399, B-08683555622082, B-08683555601001
EMDN Code
W01010201 Albumin (cc)
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000040334

Other devices from Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

See all devices from Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No