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Hematology Reagent Kit

by Shenzhen Channel Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref BCR002EU01, BCR002EU02, BCR002EU03, BCR002EU04Model HVG-3: 5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968301272 Basic UDI-DIDate28 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
HVG-3: 5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box., BCR002EU01, BCR002EU02, BCR002EU03, BCR002EU04
Primary DI / UDI-DI
06976968301272
Basic UDI-DI
B-06976968301272
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

Show 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