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Tracheostomy Tube
EUDAMEDClass IIa (EU MDR)
Ref EC130135UCModel standard, Uncuff, ID 3.5
Identity
- Trade Name
- Tracheostomy Tube EUDAMED
- Device Name
- Tracheostomy Tube EUDAMED
- Model / Reference
- standard, Uncuff, ID 3.5 EUDAMEDEC130135UC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941951011926 EUDAMED
- Basic UDI-DI
- B-06941951011926 EUDAMED
- EMDN Code
- R010503 TRACHEOSTOMY INNER CANNULAS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tracheostomy Tube by Guangdong Ecan Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941951011926 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Ecan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020906
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED a39830f6-373f-4c06-8224-5fac28e74fdb 61 fields · synced Jun 18, 2026