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Non-vascular Ni-Ti Alloy Self-expanding Stent System
EUDAMEDClass IIb (EU MDR)
Ref CRKT-2228080UC
Identity
- Device Name
- Non-vascular Ni-Ti Alloy Self-expanding Stent System EUDAMED
- Model / Reference
- CRKT-2228080UC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951862249899 EUDAMED
- Basic UDI-DI
- B-06951862249899 EUDAMED
- EMDN Code
- P0503 COLONIC AND DUODENAL PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Non-vascular Ni-Ti Alloy Self-expanding Stent System by Changzhou Health Microport Medical Device Co., Ltd — Class IIb — MDD — listed in EUDAMED
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-06951862249899 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Changzhou Health Microport Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000033536
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED bd3dfa2e-29dc-4667-bfde-179be313b092 61 fields · synced Oct 6, 2026