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Welllead Tracheal Tube with Evacuation Lumen
EUDAMEDClass IIa (EU MDR)
Ref A01G05804FModel Standard Tracheal Tube,PU cuffed, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 mm
Identity
- Trade Name
- Welllead Tracheal Tube with Evacuation Lumen EUDAMED
- Device Name
- Tracheal Tube EUDAMED
- Model / Reference
- Standard Tracheal Tube,PU cuffed, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 mm EUDAMEDA01G05804F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944932784246 EUDAMED
- Basic UDI-DI
- 69449327FA01G01CW EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Welllead Tracheal Tube with Evacuation Lumen by Well Lead Medical 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 | 69449327FA01G01CW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000006728
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 11c4873a-0c08-4a10-9dd1-4bb19d7dc23f 61 fields · synced Jul 25, 2026