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Hematology Reagent Kit

by Shenzhen Channel Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref BCR001EU01, BCR001EU02, BCR001EU03, BCR001EU04, BCR001EU05Model HVG-5：5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968301265 Basic UDI-DIDate28 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  • Withdrawn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

Model / Reference
HVG-5：5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box, BCR001EU01, BCR001EU02, BCR001EU03, BCR001EU04, BCR001EU05
Primary DI / UDI-DI
06976968301265
Basic UDI-DI
B-06976968301265
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000053778
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Shenzhen Channel Biotechnology Co., Ltd.

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Properties

  • Reagent

Other properties (9)

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