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SDO® Sleeve with 0 - 4 panels

by Medigarments Ltd 2 variants

Ref PCP06

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 Number506059893TF60007B Basic UDI-DI 05060598930979UDI-DIDate20 Sep 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  • Withdrawn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
SDO Sensory Dynamic Orthosis
Model / Reference
PCP06
Primary DI / UDI-DI
05060598930979
Basic UDI-DI
506059893TF60007B
Direct Marketing DI
05060598930979
EMDN Code
Y060609 Wrist (forearm) orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
UK-MF-000037313
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Medigarments Ltd

See all devices from Medigarments Ltd →

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