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Soft Collar

by Orthotech Rehabilitation Co., Ltd. China EUDAMED

Ref 120001(XS/UNI/Gray&Silver)Model Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 K Collar:121401

EMDN Y060312

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47199644612W5 Basic UDI-DIDate14 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Collar (Cervical spine collar)
Model / Reference
Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 K Collar:121401, 120001(XS/UNI/Gray&Silver)
Primary DI / UDI-DI
04719892934916
Basic UDI-DI
47199644612W5
EMDN Code
Y060312 Cervical spine orthoses
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000051924
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Orthotech Rehabilitation Co., Ltd.

See all devices from Orthotech Rehabilitation Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED c9dd31db-a16b-4052-874b-8a5c763725a9 61 fields · synced 24 Oct 2026