Identity
- Trade Name
- WaltzTM CoCr Coronary Stent System EUDAMED
- Device Name
- WALTZ CoCr Coronary Stent System EUDAMED
- Model / Reference
- TG2508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939963801147 EUDAMED
- Basic UDI-DI
- B-06939963801147 EUDAMED
- EMDN Code
- P070402010102 METALLIC NON-STAINLESS STEEL CORONARY STENTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
WaltzTM CoCr Coronary Stent System by Shanghai MicroPort Medical (Group) Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06939963801147 | Class III | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort Medical (Group) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001110
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 2a7dc07f-0e98-430d-a9e9-921e994cc8c1 61 fields · synced Jun 19, 2026