Identity
- Trade Name
- EPSA Series EUDAMED
- Device Name
- EPSA Series EUDAMED
- Model / Reference
- IG0E050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58050040991070 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
The EPSA Series medical device is a Class IIa implantable system designed to provide precise sterile and reprocessed solutions for various applications. With its advanced technology and user-friendly interface, it offers unparalleled ease of use, allowing healthcare professionals to deliver high-quality care with minimal training and effort.
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 157a3860-8aa3-4523-9f8d-1e34537579ae 61 fields · synced Jul 24, 2026