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Αυχενικο Κολαρο Μαλακο 8

by Λ. Κυριτσης Ορθοπαιδικα Α.Ε.Β.Ε.

Ref 13331Model 13331,35209,35237,35238,35548,04171,04172,04173,04174,04176,04194,04195,04196,04198,04410,05047,05048,05049,05050,11009,11010

Active European Union

CE MDR

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number521300745NKLS Basic UDI-DI 05213008032071UDI-DIDate6 Nov 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  • Withdrawn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
Cervical Braces
Model / reference
13331, 35209, 35237, 35238, 35548, 04171, 04172, 04173, 04174, 04176, 04194, 04195, 04196, 04198, 04410, 05047, 05048, 05049, 05050, 11009, 11010
Primary DI / UDI-DI
05213008032071
Basic UDI-DI
521300745NKLS
EMDN code
Y060312 Cervical spine orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
EL-MF-000050931

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Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No