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Cervical collar
EUDAMEDClass I (EU MDR)
Ref CS006Model CS001 CS002 CS 03 CS004 CS005 CS006 KB006
Identity
- Device Name
- Cervical collar EUDAMED
- Model / Reference
- CS001 CS002 CS 03 CS004 CS005 CS006 KB006 EUDAMEDCS006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761671 EUDAMED
- Basic UDI-DI
- 697581676CC001H3 EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Cervical collar by Xiamen Huakang Orthopedic 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 | 697581676CC001H3 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED aec15430-beca-4a8e-b6b6-fa092e4d87c9 61 fields · synced Jun 19, 2026