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Límec fixační latexový, Typ 7, 8 cm

by PROTETIKA, a.s. 2 variants

Ref 8585063861949Model Cervical spine orthose

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 Number8585065018243LFL78SK7 Basic UDI-DI 08585063861949UDI-DIDate10 Jul 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  • Withdrawn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

Model / Reference
Cervical spine orthose, 8585063861949
Primary DI / UDI-DI
08585063861949
Basic UDI-DI
8585065018243LFL78SK7
Direct Marketing DI
08585063861949
EMDN Code
Y060312 Cervical spine orthoses
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
SK-MF-000004489

Other devices from PROTETIKA, a.s.

See all devices from PROTETIKA, a.s. →

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