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HPV Genotyping Real-Time PCR Kit (Fluorescent PCR)

by Hangzhou Bioer Technology Co., Ltd. 2 variants

Ref BSJ01L1Model BSJ01M1， BSJ01L1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697384322BSJ01JA Basic UDI-DI 06973843227795UDI-DIDate20 Aug 2026RegisteredStatusActive

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  • Withdrawn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
BSJ01M1， BSJ01L1, BSJ01L1
Primary DI / UDI-DI
06973843227795
Basic UDI-DI
697384322BSJ01JA
Direct Marketing DI
06973843227795
EMDN Code
W0105041004 Full genotyping high-risk + low-risk hpv - na reagents
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019512
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Bioer Technology Co., Ltd.

See all devices from Hangzhou Bioer Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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