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FlashPoint™ Cable for Renal Artery RF Ablation Catheter
EUDAMEDClass I (EU MDR)
Ref EPK250HModel EPK250R, EPK250ST, EPK250H, EPL250C
Identity
- Trade Name
- FlashPoint™ Cable for Renal Artery RF Ablation Catheter EUDAMED
- Device Name
- FlashPoint™ Cable for Renal Artery RF Ablation Catheter EUDAMED
- Model / Reference
- EPK250R, EPK250ST, EPK250H, EPL250C EUDAMEDEPK250H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450949924 EUDAMED
- Basic UDI-DI
- 69524509C6B04FR EUDAMED
- EMDN Code
- C020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FlashPoint™ Cable for Renal Artery RF Ablation Catheter by Shanghai Microport Ep Medtech Co., Ltd. — Class I — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69524509C6B04FR | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort EP MedTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008518
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 9917b64a-28be-449b-af5c-f03204cc2084 61 fields · synced Jun 18, 2026