← Back to catalogue
Welllead Tracheal Tube with Evacuation Lumen
EUDAMEDClass IIa (EU MDR)
Ref A01F05651FModel Standard Tracheal Tube HVLP cuffed: 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0,18.5, 9.0, 9.5,10.0, 10.5, 11.0 mm
Identity
- Trade Name
- Welllead Tracheal Tube with Evacuation Lumen EUDAMED
- Device Name
- Tracheal Tube EUDAMED
- Model / Reference
- Standard Tracheal Tube HVLP cuffed: 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0,18.5, 9.0, 9.5,10.0, 10.5, 11.0 mm EUDAMEDA01F05651F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944932783652 EUDAMED
- Basic UDI-DI
- 69449327FA01A00BW 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
Similar devices
Also classified as Basic endotracheal tube, single-use.
- AVANOS — Avanos Medical, Inc. · Class II
- Parker Flex-Tip — SALTER LABS · Class II
- Mallinckrodt — Covidien LP · Class II
- RediTube™ — Airlife, Inc. · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- Endotracheal Tubes — Dynarex Corp. · Class II
- ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 3 — Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) · Class IIa
- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
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 | 69449327FA01A00BW | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 aa228fc2-1def-4c08-9d1e-e22825e30efb 61 fields · synced Jul 16, 2026