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Fit

by Radii Devices Ltd

Ref 283Model Adaptive Templates Fitting System (ATFS), Commercial Name- Fit

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5065025153283TM Basic UDI-DI 05065025153006UDI-DIDate20 Mar 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  • Withdrawn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
Adaptive Templates Fitting System (ATFS), Commercial Name- Fit
Model / Reference
Adaptive Templates Fitting System (ATFS), Commercial Name- Fit, 283
Primary DI / UDI-DI
05065025153006
Basic UDI-DI
5065025153283TM
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
UK-MF-000050607
Authorised representative
European Healthcare & Device Solutions Ltd. IE-AR-000003999

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