Identity
- Trade Name
- Tracheostomy Tube EUDAMED
- Device Name
- Tracheostomy Tube EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974909511445 EUDAMED06974909511469 EUDAMED06974909511384 EUDAMED06974909511315 EUDAMED06974909511353 EUDAMED06974909511414 EUDAMED06974909511476 EUDAMED06974909511360 EUDAMED06974909511483 EUDAMED06974909511421 EUDAMED06974909511377 EUDAMED06974909511308 EUDAMED06974909511391 EUDAMED06974909511452 EUDAMED
- Basic UDI-DI
- 697299186CA1302F7 EUDAMED697299186CA1301F5 EUDAMED
- EMDN Code
- R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMEDR0105020101 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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Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
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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 | 697299186CA1302F7 | 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 (14)
- EUDAMED fd2cbb77-2a18-4a77-b83a-cb17e9083e3c 61 fields · synced Oct 6, 2026
- EUDAMED 856835ab-be13-4c77-8d29-3eb1b4519366 61 fields · synced May 16, 2026
- EUDAMED b3a0236c-1e86-43f6-af00-351a789423ca 61 fields · synced May 16, 2026
- EUDAMED b643c93f-187a-49f3-838f-fe650c63fb1b 61 fields · synced May 17, 2026
- EUDAMED c5fbc634-8088-441e-ad5d-ece56505b90f 61 fields · synced May 17, 2026
- EUDAMED 27443626-be6f-463b-837b-c0a4d7dc145a 61 fields · synced May 17, 2026
- EUDAMED 9f382889-97e0-4c1d-bcaa-849952b933cc 61 fields · synced May 17, 2026
- EUDAMED 5e05b11c-bba9-43d1-acd0-bdb923b23e2d 61 fields · synced May 17, 2026
- EUDAMED 88cf702e-4ea8-4e7a-b89f-ce125f86f002 61 fields · synced May 18, 2026
- EUDAMED f11e6b40-58bb-4366-bdec-10a5942d6236 61 fields · synced May 18, 2026
- EUDAMED f6381f42-10f3-4333-9c87-aa51a5fe6765 61 fields · synced May 18, 2026
- EUDAMED b2bfe97d-42d5-4834-b90f-f34d04db6ef4 61 fields · synced May 18, 2026
- EUDAMED 8ce51ec6-e117-4b4a-82e0-7e314da71240 61 fields · synced May 19, 2026
- EUDAMED 73aed2b2-8f2f-45c1-a451-60e0c7580737 61 fields · synced May 19, 2026