Skip to content

PCT Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd. 8 variants

Ref CPC-N302J-10, CPC-N302J-25, CPC-N302-25, CPC-N402J-10, CPC-N402B-25

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR Number6970277510000XYR Basic UDI-DI Date15 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
CPC-N302J-10, CPC-N302J-25, CPC-N302-25, CPC-N402J-10, CPC-N402B-25
Primary DI / UDI-DI
06936983116008, 06936983116015, 06936983104777, 06936983116022, 06936983115667
Basic UDI-DI
6970277510000XYR, 6970277510014LYJ
EMDN Code
W0102160999 Individual and specific hormones/proteins rt & poc - other
Device Class
Class C
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device YesEUDAMEDNoEUDAMED

Other properties (7)

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