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K Collar
EUDAMEDClass I (EU MDR)
Ref 121401(Universal/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
Identity
- Trade Name
- K Collar 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 EUDAMED121401(Universal/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463283 EUDAMED
- Basic UDI-DI
- 47199644612W5 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
K Collar 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47199644612W5 | Class I | Active |
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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 (1)
- EUDAMED d9fce4a2-7ef3-44f0-b638-e6d4e5ff94f0 61 fields · synced Oct 6, 2026