← Back to catalogue
Tracheal Tube
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A01C01951FModel Nasal 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, 8.5, 9.0, 9.5, 10.0 mm
Identity
- Trade Name
- Tracheal Tube EUDAMEDWell Lead Endotracheal Tube FDA UDI
- Generic Name
- Basic endotracheal tube, single-use FDA UDI
- Device Name
- Tracheal Tube EUDAMEDEndotracheal Tubes with Cuff (Nasal)9.5 FDA UDI
- Model / Reference
- Nasal 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, 8.5, 9.0, 9.5, 10.0 mm EUDAMEDA01C01951F EUDAMEDFDA UDI
- Description
- Endotracheal Tubes with Cuff (Nasal)9.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932780446 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FA01C00C8 EUDAMED
- 510(k) Number
- K042683 FDA UDI
- FDA Product Code
- BTR FDA UDI
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
- GMDN Term
- Basic endotracheal tube, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic endotracheal tube, single-use
Tracheal Tube by Well Lead Medical Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69449327FA01C00C8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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 (2)
- EUDAMED c19c9ac0-7c5a-4b8d-b965-318d2f0e7383 61 fields · synced Jun 19, 2026
- FDA UDI 34feeea5-564e-4a1e-bd83-7494306cb62c 34 fields · synced May 30, 2026