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Transtibial Liner Without Connection Derma with Fabric Pro Co

by Ortho Pauher Industria Comercio E Distribuicoes Ltda

Ref HQF40GT

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 Number789994730016P Basic UDI-DI Date10 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  • Withdrawn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
Orthosis, Liner, Valve
Model / Reference
HQF40GT
Primary DI / UDI-DI
07899947329830, 07899947329786, 07899947329823, 07899947329816, 07899947329991, 07899947329793, 07899947329984, 07899947329809
Basic UDI-DI
789994730016P
EMDN Code
Y061280 Lower limb orthoses - accessories
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
BR-MF-000055005
Authorised representative
Rápido e Contínuo Unipessoal LDA PT-AR-000039288

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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