Identity
- Trade Name
- Tracheostomy Tube EUDAMED
- Device Name
- Tracheostomy Tube EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974909511346 EUDAMED
- Basic UDI-DI
- 697299186CA1301F5 EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Tracheostomy Tube by Medcaptain Life Science Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697299186CA1301F5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medcaptain Life Science Co., Ltd.
- EUDAMED SRN
- CN-MF-000006656
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ca7ab09c-e44c-4c8c-81dc-868a5ec53d86 61 fields · synced Jun 19, 2026