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Tilty 320 size 40"

by Awatar Medical Aid d.o.o.

Ref AWCF002Model Pema 300 Lightweight Wheelchair with Reclining Backrest

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number385889357AWCF001WD Basic UDI-DI 03858893570493UDI-DIDate22 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  • Withdrawn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
Pema 300 Lightweight Wheelchair with Reclining Backrest
Model / Reference
Pema 300 Lightweight Wheelchair with Reclining Backrest, AWCF002
Primary DI / UDI-DI
03858893570493
Basic UDI-DI
385889357AWCF001WD
Direct Marketing DI
03858893570493
EMDN Code
Y122103 Push wheelchairs
Device Class
Class I
EU market of registration
Croatia

Manufacturer details

EUDAMED SRN
HR-MF-000025777

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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