← Back to catalogue
Tracheotomy Collar
EUDAMEDClass I (EU MDR)
Ref 120003(L2/UNI/Beige)Model Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 K Collar:121401Ref 120003(S2/UNI/Beige)Ref 120003(L/UNI/Beige)Ref 120003(L3/UNI/Beige)Ref 120003(XL2/UNI/Beige)
Identity
- Trade Name
- Tracheotomy Collar EUDAMED
- Device Name
- Collar (Cervical spine collar) EUDAMED
- Model / Reference
- Soft Collar:120001 Soft Collar:120002 Tracheotomy Collar:120003 Rigid Splint Collar:120004 Rigid Splint Collar With Chin Support:120005 K Collar:121401 EUDAMED120003(L2/UNI/Beige) EUDAMED120003(S2/UNI/Beige) EUDAMED120003(L/UNI/Beige) EUDAMED120003(L3/UNI/Beige) EUDAMED120003(XL2/UNI/Beige) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892934985 EUDAMED04719892935043 EUDAMED04719892934978 EUDAMED04719892934992 EUDAMED04719892935050 EUDAMED
- Basic UDI-DI
- 47199644612W5 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Tracheotomy Collar by Orthotech 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 | 47199644612W5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 91e86330-a953-4965-b807-2b955a51b9be 61 fields · synced Oct 7, 2026
- EUDAMED f6da8828-6363-4da3-b6d0-abe5f342ef43 61 fields · synced May 18, 2026
- EUDAMED 879deb3c-4f52-4470-983b-bfe3e8857698 61 fields · synced May 18, 2026
- EUDAMED 250a9b1b-7fef-4f5a-a421-e5f2487f6877 61 fields · synced May 19, 2026
- EUDAMED a9f277d5-d652-40fb-b835-5f61364b284f 61 fields · synced May 19, 2026