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Rigid Splint Collar With Chin Support

EUDAMED

Class I (EU MDR)

Ref 120005(M/UNI/White)Model Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 K Collar:121401Ref 120005(S/UNI/White)

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
Rigid Splint Collar With Chin Support EUDAMED
Device Name
Collar (Cervical spine collar) EUDAMED
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 EUDAMED
120005(M/UNI/White) EUDAMED
120005(S/UNI/White) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892935111 EUDAMED
04719892935128 EUDAMED
Basic UDI-DI
47199644612W5 EUDAMED
EMDN Code
Y060312 CERVICAL SPINE ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Rigid Splint Collar With Chin Support by Orthotech Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Orthotech Rehabilitation Co., Ltd.
EUDAMED SRN
CN-MF-000051924
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED 4f4a2840-1f51-460d-81fd-71c11458512c 61 fields · synced Oct 6, 2026
  • EUDAMED f3bfc4bd-84e9-4201-9a4d-d1c54cbee1c1 61 fields · synced May 18, 2026