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Fosun 2019-nCoV qPCR

by Fosun Diagnostics (Shanghai) Co., Ltd. EUDAMED

Active European Union

Ref PCSYHF02-e （48 tests/kit）

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06931654310075 Basic UDI-DIDate28 Sep 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
Model / Reference
PCSYHF02-e （48 tests/kit）
Primary DI / UDI-DI
06931654310075
Basic UDI-DI
B-06931654310075
EMDN Code
W0105040519
Device Class
Class IVD General
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000028169
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Fosun Diagnostics (Shanghai) Co., Ltd.

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