Tracheotomy Collar
by Zhangpu Ortholife Rehabilitation Co., Ltd. 9 variants
Ref 120003(L3/UNI/Beige)Model K Collar:121401 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47198728612W7 04719872860136 | Date15 Apr 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Collar (Cervical spine collar)
- 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, 120003(L3/UNI/Beige)
- Primary DI / UDI-DI
- 04719872860136
- Basic UDI-DI
- 47198728612W7
- EMDN Code
- Y060312 Cervical spine orthoses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000011447
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhangpu Ortholife Rehabilitation Co., Ltd.
See all devices from Zhangpu Ortholife Rehabilitation Co., Ltd. →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No