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Prostate Specific Antigen Rapid Test

by Shanghai Chemtron Biotech Co., Ltd. China EUDAMED

Ref 9002C

EMDN W0102160202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNM0000180729002NP Basic UDI-DIDate25 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Prostate Specific Antigen Rapid Test
Model / Reference
9002C
Primary DI / UDI-DI
D-CNM0000180729002NP
Basic UDI-DI
B-CNM0000180729002NP
EMDN Code
W0102160202 Psa - rt & poc
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai Chemtron Biotech Co., Ltd.

See all devices from Shanghai Chemtron Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 8afa0539-c381-4741-adbd-5485eed0b7dd 61 fields · synced 22 Oct 2026