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PathTezt Disposable Cell Sampling Device - Cervical Brush

by Biocytech Corporation Sdn Bhd

Ref CB1-10100Model CB1-10100，CB2-10100，CB3-10100，CB4-10100，CB5-10100，CBC-10100，CBS-10100

Active European Union

CE MDR

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955102041CellsamplingNK Basic UDI-DI 09551020410122UDI-DIDate30 Oct 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Disposable Cell Sampling Device
Model / Reference
CB1-10100，CB2-10100，CB3-10100，CB4-10100，CB5-10100，CBC-10100，CBS-10100, CB1-10100
Primary DI / UDI-DI
09551020410122
Basic UDI-DI
955102041CellsamplingNK
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class I
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
MY-MF-000047354
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Biocytech Corporation Sdn. Bhd.

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No