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Endotracheal Tubes for Single Use
EUDAMEDClass IIa (EU MDR)
Ref /Model Standard with cuff, Standard without cuff, Reinforced with cuff, Reinforced without cuff
Identity
- Trade Name
- Endotracheal Tubes for Single Use EUDAMED
- Device Name
- Endotracheal Tubes for Single Use EUDAMED
- Model / Reference
- Standard with cuff, Standard without cuff, Reinforced with cuff, Reinforced without cuff EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948097060016 EUDAMED06948097060009 EUDAMED
- Basic UDI-DI
- 6948097004GQCGDH EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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: Basic endotracheal tube, single-use
Endotracheal Tubes for Single Use by Haiyan Kangyuan Medical Instrument 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 | 6948097004GQCGDH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Haiyan Kangyuan Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001532
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 794082cc-7184-4096-8e95-63e8ec0fd733 61 fields · synced Jul 10, 2026
- EUDAMED 0e004e1f-fcac-4536-ae52-bc5d9e8e6972 61 fields · synced May 18, 2026