Skip to content

Orteza nadgarstka długa (Ortopedio by Synoptis)

by Private Enterprise Remed 3 variants

Ref 04820183234124Model R8301

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 Number018323R8301TK Basic UDI-DI 04820183234124UDI-DIDate22 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  • Withdrawn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
Wrist splint
Model / Reference
R8301, 04820183234124
Primary DI / UDI-DI
04820183234124
Basic UDI-DI
018323R8301TK
EMDN Code
Y060609 Wrist (forearm) orthoses
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
UA-MF-000056451
Authorised representative
GSI-CERT German Scientific Institute for Quality, Testing and Certification GmbH DE-AR-000056188

Other devices from Private Enterprise Remed

See all devices from Private Enterprise Remed →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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