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Hdl Kolesterol Di̇rekt Ki̇ti̇

by Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref 08V4525

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08681812530637 Basic UDI-DIDate3 Jul 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  • Withdrawn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

Device Name
Hdl Cholesterol Direct Reagent
Model / Reference
08V4525
Primary DI / UDI-DI
08681812530637
Basic UDI-DI
B-08681812530637
EMDN Code
W01010215 High density lipoprotein cholesterol
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000027166

Other devices from Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Archem Sağlik Sanayi̇ Ve Ti̇caret 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