Wellead Bile-T Tube
by Well Lead Medical Co., Ltd. 8 variants
Ref N01D052020, N01D051620, N01D052420, N01D051420, N01D053020, N01D051430, N01D051230, N01D052620, N01D052430, N01D053030, N01D052820, N01D052230Model Bile T-Tube
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449327FN01D05HY | Date10 Feb 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Bile T-Tube
- Model / Reference
- Bile T-Tube, N01D052020, N01D051620, N01D052420, N01D051420, N01D053020, N01D051430, N01D051230, N01D052620, N01D052430, N01D053030, N01D052820, N01D052230
- Primary DI / UDI-DI
- 06944932785441, 06944932785366, 06944932785526, 06944932785328, 06944932785625, 06944932785335, 06944932785304, 06944932785564, 06944932785533, 06944932785632, 06944932785595, 06944932785496
- Basic UDI-DI
- 69449327FN01D05HY
- EMDN Code
- U040203 Nephrostomy catheters
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000006728
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Well Lead Medical Co., Ltd
Properties
Other properties (11)
- Implantable: No
- Reusable: 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