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Human Papillomavirus Self Sample Collection Kit

by Jiangsu Mole Bioscience Co., LTD. 5 variants

Ref PG03010I04C2001

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, self-declared

Class I: no certifier involved

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 Number697089547HPVSSC00X5 Basic UDI-DI 06970895478656UDI-DIDate26 Oct 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Human Papillomavirus Self Sample Collection Kit
Model / Reference
PG03010I04C2001
Primary DI / UDI-DI
06970895478656
Basic UDI-DI
697089547HPVSSC00X5
EMDN Code
A1102 Sample collection swabs with transport medium
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000001539
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: General-purpose absorbent tip applicator/swab, single-use

Other devices from Jiangsu Mole Bioscience Co., LTD.

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Properties

  • Reagent
  • Self Testing

Other properties (9)

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