Skip to content

ADULT 2FL z paznokciami

by vBionic Sp. z o.o.

Ref ADULT 2FL z paznokciamiModel Tolka kosmetyczna proteza ręki

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 Number5906138350TolkaQP Basic UDI-DI 05906138350329UDI-DIDate31 Aug 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  • Withdrawn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
Tolka kosmetyczna proteza ręki
Model / Reference
Tolka kosmetyczna proteza ręki, ADULT 2FL z paznokciami
Primary DI / UDI-DI
05906138350329
Basic UDI-DI
5906138350TolkaQP
EMDN Code
Y061809 Transradial prostheses (for amputation under elbow)
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000056684

Other devices from vBionic Sp. z o.o.

See all devices from vBionic Sp. z o.o. →

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