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Preformed Oral Tracheal Tube Ruschelit
EUDAMEDClass IIa (EU MDR)
Ref 111780-000035
Identity
- Trade Name
- Preformed Oral Tracheal Tube Ruschelit EUDAMED
- Device Name
- TRACHEAL TUBE, CUFFED, ORAL PREFORM EUDAMED
- Model / Reference
- 111780-000035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704195678 EUDAMED
- Basic UDI-DI
- B-14026704195678 EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Preformed Oral Tracheal Tube Ruschelit by Teleflex Medical Sdn. Bhd. — Class IIa — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14026704195678 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000024692
- Authorised Representative
- Teleflex Medical IE-AR-000015869
Sources (1)
- EUDAMED 4f3aa62c-ecbf-40a8-a2e5-507c2394c439 61 fields · synced Aug 1, 2026