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Padx

by WomenX Biotech Limited 6 variants

Ref B01-CE8

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489715770B01P5 Basic UDI-DI 4897157700060UDI-DIDate16 Sep 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  • Withdrawn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

Model / Reference
B01-CE8
Primary DI / UDI-DI
4897157700060
Basic UDI-DI
489715770B01P5
Direct Marketing DI
4897157700060
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
HK-MF-000058825
Authorised representative
OSMUNDA Medical Technology Service GmbH DE-AR-000009285

Other devices from WomenX Biotech Limited

  • Padx

    Class I

  • Padx

    Class I

  • Padx

    Class I

  • Padx

    Class I

  • Padx

    Class I

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