WaltzTM CoCr Coronary Stent System
by Shanghai MicroPort Medical (Group) Co., Ltd. 25 variants
Ref TG4031
Active
CE MDD
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/MDD | NumberB-06939963801055 06939963801055 | Date11 May 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- WALTZ CoCr Coronary Stent System
- Model / Reference
- TG4031
- Primary DI / UDI-DI
- 06939963801055
- Basic UDI-DI
- B-06939963801055
- EMDN Code
- P070402010102 Metallic non-stainless steel coronary stents
- Device Class
- Class III
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000001110
- Authorised representative
- MicroPort Medical B.V. NL-AR-000000166
Other devices from Shanghai MicroPort Medical (Group) Co., Ltd.
See all devices from Shanghai MicroPort Medical (Group) Co., Ltd. →
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No