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Soft Collar
EUDAMEDClass I (EU MDR)
Ref 120001(S/UNI/Gray&Silver)Model K Collar:121401 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003
Identity
- Trade Name
- Soft Collar EUDAMED
- Device Name
- Collar (Cervical spine collar) EUDAMED
- Model / Reference
- K Collar:121401 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 EUDAMED120001(S/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872860037 EUDAMED
- Basic UDI-DI
- 47198728612W7 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
Soft Collar by Zhangpu Ortholife 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 | 47198728612W7 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2d9e37b4-ef03-427c-875f-41f9a0101b1b 61 fields · synced Oct 9, 2026