Well Lead Tracheostomy Tube A02A019610
Ref A02A05751F, A02A06303F, A02C01651F, A02A06953F, A02A06803F, A02A05401F, A02A05961F, A02A06453F, A02A05601F, A02A06753F, A02A05351F, A02A06703F, A02A05651F, A02C01801F, A02A06903F, A02A06603F, A02A05501F, A02A05901F, A02A06853F, A02A06353F, A02A06553FModel Tracheostomy Tube, SuctionPlus Tracheostomy Tube with Evacuation Lumen
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69449327FA02A01C7 | Date31 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06944932784512 | Date21 Mar 2024 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Welllead Tracheostomy Tube EUDAMEDWell Lead Tracheostomy Tube GUDID
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, single-use
- Device Name
- Tracheostomy Tube
- Model / Reference
- Tracheostomy Tube EUDAMEDA02A05751F EUDAMEDA02A06303F EUDAMEDSuctionPlus Tracheostomy Tube with Evacuation Lumen EUDAMEDA02C01651F EUDAMEDA02A06953F EUDAMEDA02A06803F EUDAMEDA02A05401F EUDAMEDA02A05961F EUDAMEDA02A06453F EUDAMEDA02A05601F EUDAMEDA02A06753F EUDAMEDA02A05351F EUDAMEDA02A06703F EUDAMEDA02A05651F EUDAMEDA02C01801F EUDAMEDA02A06903F EUDAMEDA02A06603F EUDAMEDA02A05501F EUDAMEDA02A05901F EUDAMEDA02A06853F EUDAMEDA02A06353F EUDAMEDA02A06553F EUDAMEDA02A019610 GUDID
- Primary DI / UDI-DI
- 06944932784512 EUDAMED06944932784581 EUDAMED06944932784901 EUDAMED06944932784840 EUDAMED06944932784789 EUDAMED06944932784383 EUDAMED06944932784567 EUDAMED06944932784642 EUDAMED06944932784468 EUDAMED06944932784765 EUDAMED06944932784369 EUDAMED06944932784741 EUDAMED06944932784482 EUDAMED06944932784963 EUDAMED06944932784826 EUDAMED06944932784703 EUDAMED06944932784420 EUDAMED06944932784543 EUDAMED06944932784802 EUDAMED06944932784604 EUDAMED06944932784680 EUDAMED06944932702783 GUDID
- Basic UDI-DI
- 69449327FA02A01C7, 69449327FA02A02C9, 69449327FA02A03CB
- 510(k) Number
- FDA Product Code
- BTO
- EMDN Code
- R0105020101, R0105010101
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, single-use
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 868.5800
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Tracheostomy Tube A02A05751F A02A06303F SuctionPlus Tracheostomy Tube with Evacuation Lumen A02C01651F A02A06953F A02A06803F A02A05401F A02A05961F A02A06453F A02A05601F A02A06753F A02A05351F A02A06703F A02A05651F A02C01801F A02A06903F A02A06603F A02A05501F A02A05901F A02A06853F A02A06353F A02A06553F | A02A019610 |
| Primary DI / UDI-DI | 06944932784512 06944932784581 06944932784901 06944932784840 06944932784789 06944932784383 06944932784567 06944932784642 06944932784468 06944932784765 06944932784369 06944932784741 06944932784482 06944932784963 06944932784826 06944932784703 06944932784420 06944932784543 06944932784802 06944932784604 06944932784680 | 06944932702783 |
| Device Class | Class IIb | Class II |
Other devices from Well Lead Medical Co., Ltd
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No