Identity
- Trade Name
- AM308N EUDAMED
- Device Name
- AM308N EUDAMED
- Model / Reference
- AM308N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8050714530012V5 EUDAMED
- Basic UDI-DI
- B-8050714530012V5 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Foot-switch, electrical
Am308n by Engineering Production Equipment Medical Srl — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-8050714530012V5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Engineering Production Equipment Medical Srl
- EUDAMED SRN
- IT-MF-000017628
Sources (1)
- EUDAMED f257e9e9-c7cc-4482-a699-0833c4b01de8 61 fields · synced Jul 28, 2026