Identity
- Trade Name
- EPSA Series EUDAMED
- Device Name
- EPSA Series EUDAMED
- Model / Reference
- IG0E090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58050040991124 EUDAMED
- Basic UDI-DI
- 805004099EPSA8Q EUDAMED
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Category: Percutaneous radio-frequency ablation system generator
EPSA Series by IGEA S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 805004099EPSA8Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- IGEA S.p.A.
- EUDAMED SRN
- IT-MF-000011242
Sources (1)
- EUDAMED baa81530-6aa8-44cc-ba8a-80377e384067 61 fields · synced Jun 18, 2026