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Endotracheal Tube
EUDAMEDClass IIa (EU MDR)
Ref STET0100Model Normal-PVCCuffed,TPUCuffed,Uncuffed,LubriciousCoating,Adaptive-cuff,Suction,Injectable,Supraglottic&SubglotticInjectable,Soft-tip;OralPreformed-PVCCuffed,Uncuffed,LubriciousCoating,Soft-tip;NasalPreformed-PVCCuffed,Uncuffed,LubriciousCoating,Soft-tip
Identity
- Device Name
- Endotracheal Tube EUDAMED
- Model / Reference
- Normal-PVCCuffed,TPUCuffed,Uncuffed,LubriciousCoating,Adaptive-cuff,Suction,Injectable,Supraglottic&SubglotticInjectable,Soft-tip;OralPreformed-PVCCuffed,Uncuffed,LubriciousCoating,Soft-tip;NasalPreformed-PVCCuffed,Uncuffed,LubriciousCoating,Soft-tip EUDAMEDSTET0100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26941617117508 EUDAMED
- Basic UDI-DI
- 693811931296J2 EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 Tube by Henan Tuoren Medical Device Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Basic endotracheal tube, 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 | 693811931296J2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henan Tuoren Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000013924
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (1)
- EUDAMED 64fc3726-23f1-4dd0-a7d7-dfd0c6bc2c10 61 fields · synced Jun 20, 2026