← Back to catalogue
Tracheal Tube
EUDAMEDClass IIa (EU MDR)
Ref A01G01404FModel 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
- Tracheal Tube 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 EUDAMEDA01G01404F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944932758841 EUDAMED
- Basic UDI-DI
- 69449327FA01G01CW EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Tracheal Tube 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 | 69449327FA01G01CW | 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 8c95e518-4b81-4055-99e1-34dd2ef67331 61 fields · synced Jun 18, 2026