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Prl (Clia)

by Drophil Biotech (Shenzhen) Company Limited EUDAMED

Active European Union

Ref 48 tests/kit: (Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNMF000042193PRLPT Basic UDI-DIDate26 May 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  • Withdrawn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
48 tests/kit: (Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)
Primary DI / UDI-DI
D-CNMF000042193PRLPT
Basic UDI-DI
B-CNMF000042193PRLPT
EMDN Code
W0102050108 Prolactin
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000042193
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Drophil Biotech (Shenzhen) Company Limited

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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