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Black FreeWheel

by Pnt LLC

Ref Black FreeWheel

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 Number8600133207FreeWheelVZ Basic UDI-DI 12400000310034UDI-DIDate23 Apr 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  • Withdrawn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
FreeWheel
Model / Reference
Black FreeWheel
Primary DI / UDI-DI
12400000310034
Basic UDI-DI
8600133207FreeWheelVZ
Direct Marketing DI
12400000310034
EMDN Code
Y122499 Wheelchairs accessories - other
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000031213
Authorised representative
Wellkang Ltd XI-AR-000001836

From the manufacturer

Manufacturer's product page: Quick ViewBest Seller

Other devices from Pnt LLC

See all devices from Pnt LLC →

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