Identity
- Device Name
- Tracheostomy Tube EUDAMED
- Model / Reference
- Tracheostomy Tube EUDAMEDTT060PC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240898863 EUDAMED
- Basic UDI-DI
- 697024089TTZJ EUDAMED
- Direct Marketing DI
- 06970240898863 EUDAMED
- EMDN Code
- R010503 TRACHEOSTOMY INNER CANNULAS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
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
Tracheostomy Tube by Ningbo Luke Medical Devices Co., LTD — Class IIa — 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 | 697024089TTZJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Luke Medical Devices Co., LTD
- EUDAMED SRN
- CN-MF-000011732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a6038afe-6422-41b5-97b6-e75164b0ca69 61 fields · synced Sep 17, 2026