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Substrate

by Taizhou Zecen Biotech Co., Ltd. EUDAMED

Active European Union

Ref 100mL/bottle, 500mL/bottle, 1000mL/bottle

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697420115SR20019W Basic UDI-DIDate19 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
100mL/bottle, 500mL/bottle, 1000mL/bottle
Primary DI / UDI-DI
06976868800929, 06976868800912, 06976868800936, 06974201150441
Basic UDI-DI
697420115SR20019W
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
Market of Registration
Germany
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000050486
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Taizhou Zecen Biotech Co., Ltd.

See all devices from Taizhou Zecen Biotech Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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