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PG I Reagent Kit

by Virtue Diagnostics (Suzhou) Co., Ltd

Ref 12001008,12001048

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CN-MF-000013251RC Basic UDI-DI D-CN-MF-000013251RCUDI-DIDate18 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
PG I Reagent Kit
Model / Reference
12001008, 12001048
Primary DI / UDI-DI
D-CN-MF-000013251RC
Basic UDI-DI
B-CN-MF-000013251RC
EMDN Code
W0102069006 Pepsinogen
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000013251
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Virtue Diagnostics (Suzhou) Co., Ltd

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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