Identity
- Trade Name
- OptimAblate™ Irrigation Pump EUDAMEDOptimAblate™ Tubing Set EUDAMED
- Device Name
- OptimAblate™ Tubing Set EUDAMED
- Model / Reference
- EPAB 3200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450970126 EUDAMED
- Basic UDI-DI
- B-06952450970126 EUDAMED69524509C6L01H5 EUDAMED
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMEDA03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
OptimAblate™ Irrigation Pump by Shanghai Microport Ep Medtech Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06952450970126 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06952450970126 | Class IIa | 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 (2)
- EUDAMED 1d83d4c4-3bf4-47a3-9b0a-1dfe6973deb2 61 fields · synced Jul 30, 2026
- EUDAMED 1ca48066-27c6-4576-acd9-128df4afbd4f 61 fields · synced Jul 30, 2026