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Rollator

by Awatar Medical Aid d.o.o. 3 variants

Ref AW RST4W X2.005Model Iroh 200

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 Number385889357AWRST4WX2.005FK Basic UDI-DI 03858893570943UDI-DIDate30 Aug 2023RegisteredStatusActive

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  • Withdrawn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
Rollator
Model / Reference
Iroh 200, AW RST4W X2.005
Primary DI / UDI-DI
03858893570943
Basic UDI-DI
385889357AWRST4WX2.005FK
Direct Marketing DI
03858893570943
EMDN Code
Y120606 Wheeled walker
Device Class
Class I
EU market of registration
Croatia

Manufacturer details

EUDAMED SRN
HR-MF-000025777

Other devices from Awatar Medical Aid d.o.o.

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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