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Alpha-fetoprotein(AFP) Control

by Shenzhen Channel Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref Multiple catalogue numbers for configurable kit combinations.Model Kit configuration : 1.0 mL / 2.0 mL Level 1, Level 2, Level 3 components ( 1 / 2 / 3 of packaging size ) of a variety of combinations, a total of 16 specifications.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968301159 Basic UDI-DIDate30 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  • Withdrawn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
Kit configuration : 1.0 mL / 2.0 mL Level 1, Level 2, Level 3 components ( 1 / 2 / 3 of packaging size ) of a variety of combinations, a total of 16 specifications., Multiple catalogue numbers for configurable kit combinations.
Primary DI / UDI-DI
06976968301159
Basic UDI-DI
B-06976968301159
EMDN Code
W0102152005 Tumour marker controls
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