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Pas lędźwiowo - krzyżowy z usztywnieniem (Ortopedio by Synoptis)

by Private Enterprise Remed 5 variants

Ref 04820183234308Model R3302

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number018323R3302SJ Basic UDI-DI 04820183234308UDI-DIDate24 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  • Withdrawn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
Lumbosacral belt with stiffening
Model / Reference
R3302, 04820183234308
Primary DI / UDI-DI
04820183234308
Basic UDI-DI
018323R3302SJ
EMDN Code
Y060308 Lumbosacral spine 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

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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