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Stylite Designs Ltd

by Stylite Designs 9 variants

Ref PiVoTModel PiVoT (Model A & S)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539154886W-PV-ASSM Basic UDI-DI 05391548860238UDI-DIDate7 Jun 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  • Withdrawn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
Stylite Designs Ltd - PiVoT (Model A & S)
Model / Reference
PiVoT (Model A & S), PiVoT
Primary DI / UDI-DI
05391548860238
Basic UDI-DI
539154886W-PV-ASSM
Direct Marketing DI
05391548860238
EMDN Code
Y122106 Rear self-propelled wheelchairs
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000035101

Other devices from Stylite Designs

See all devices from Stylite Designs →

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