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Rigid Splint Collar
EUDAMEDClass I (EU MDR)
Ref 120004(S/UNI/White)Model K Collar:121401 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003Ref 120004(XL/UNI/White)Ref 120005(L/UNI/White)Ref 120005(S/UNI/White)Ref 120005(M/UNI/White)Ref 120004(L/UNI/White)
Identity
- Trade Name
- Rigid Splint Collar EUDAMEDRigid Splint Collar With Chin Support 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 EUDAMED120004(S/UNI/White) EUDAMED120004(XL/UNI/White) EUDAMED120005(L/UNI/White) EUDAMED120005(S/UNI/White) EUDAMED120005(M/UNI/White) EUDAMED120004(L/UNI/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872860297 EUDAMED04719872860303 EUDAMED04719872860310 EUDAMED04719872860334 EUDAMED04719872860327 EUDAMED04719872860273 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
Rigid Splint 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 (6)
- EUDAMED e8f02f9f-9f6b-4f2c-b4a9-a2953a1426b3 61 fields · synced Oct 6, 2026
- EUDAMED 5849150a-9419-439a-8a53-0e6f83c2ea32 61 fields · synced May 17, 2026
- EUDAMED 162c1f46-91eb-4c8c-82ee-57fed6f0b3a4 61 fields · synced May 17, 2026
- EUDAMED 754b9eee-9186-49a9-b944-d96253be374e 61 fields · synced May 18, 2026
- EUDAMED 29998a5c-e233-48ef-88df-f4dee3aa00f2 61 fields · synced May 19, 2026
- EUDAMED 9396cdff-04f1-4f2c-a1ae-1cfdc726d0bd 61 fields · synced May 19, 2026