Identity
- Trade Name
- OptimAblate™ Cardiac RF Generator EUDAMED
- Device Name
- OptimAblate™ Cardiac RF Generator EUDAMED
- Model / Reference
- EPE-CRF-1A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450972786 EUDAMED
- Basic UDI-DI
- B-06952450972786 EUDAMED
- EMDN Code
- C020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OptimAblate™ Cardiac RF Generator by Shanghai Microport Ep Medtech Co., Ltd. — Class IIb — 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-06952450972786 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
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 138bac33-54b6-4aab-baa1-3b3474aea97b 61 fields · synced Jun 18, 2026