← Back to catalogue
Cervical collar
EUDAMEDClass I (EU MDR)
Ref KB006Model CS001 CS002 CS 03 CS004 CS005 CS006 KB006
Identity
- Device Name
- Cervical collar EUDAMED
- Model / Reference
- CS001 CS002 CS 03 CS004 CS005 CS006 KB006 EUDAMEDKB006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761688 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 56d7bae0-8048-4a83-bab5-c52cc36af23f 61 fields · synced Oct 5, 2026