← Back to catalogue
Soft Collar
EUDAMEDClass I (EU MDR)
Ref 120001(M/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:120003Ref 120002(M/UNI/Gray&Silver)Ref 120002(S/UNI/Gray&Silver)Ref 120002(XS/UNI/Gray&Silver)Ref 120001(XL/UNI/Gray&Silver)
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(M/UNI/Gray&Silver) EUDAMED120002(M/UNI/Gray&Silver) EUDAMED120002(S/UNI/Gray&Silver) EUDAMED120002(XS/UNI/Gray&Silver) EUDAMED120001(XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872868774 EUDAMED04719872860082 EUDAMED04719872860099 EUDAMED04719872868781 EUDAMED04719872860044 EUDAMED
- Basic UDI-DI
- 47198728612W7 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDNetherlands 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 8cca42d2-ae8f-407e-b58f-c3423de927f6 61 fields · synced Oct 6, 2026
- EUDAMED ab35f7ab-82ba-4272-b98b-6a41e3ab5808 61 fields · synced May 16, 2026
- EUDAMED 59d88a03-4a19-41c7-aa54-54591891d1e0 61 fields · synced May 17, 2026
- EUDAMED 0e8e96e0-92ae-4126-9299-65f26239c301 61 fields · synced May 17, 2026
- EUDAMED ae56dc71-d8a9-4ce0-bc95-5d4af23331f2 61 fields · synced May 18, 2026