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Tracheostomy Tubes
EUDAMEDClass IIa (EU MDR)
Ref TT-P3-60Model TT-P2, TT-P3, TT-P4, TT-P5, TT-J2, TT-J3, TT-J4, TT-J5, TT-X2, TT-X3, TT-X4, TT-X5, TT-XC2, TT-XC3, TT-XC4, TT-XC5
Identity
- Trade Name
- Tracheostomy Tubes EUDAMED
- Device Name
- Tracheostomy Tubes EUDAMED
- Model / Reference
- TT-P2, TT-P3, TT-P4, TT-P5, TT-J2, TT-J3, TT-J4, TT-J5, TT-X2, TT-X3, TT-X4, TT-X5, TT-XC2, TT-XC3, TT-XC4, TT-XC5 EUDAMEDTT-P3-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920687301983 EUDAMED
- Basic UDI-DI
- 69206873TT002QX EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIa 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 Tubes by Tianjin Medis Medical Device 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 | 69206873TT002QX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianjin Medis Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000020126
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1f11fa34-9c8e-48ff-9387-7b3f12481985 61 fields · synced Jul 31, 2026