Identity
- Trade Name
- PulsWave Plus EUDAMED
- Device Name
- PULSWAVE PLUS EUDAMED
- Model / Reference
- PULSWAVE 2 EUDAMED11MMP.PW.0,2JF10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051499970147 EUDAMED
- Basic UDI-DI
- B-08051499970147 EUDAMED
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
PulsWave Plus by Mectronic Medicale Srl — Class IIa — 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-08051499970147 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mectronic Medicale srl
- EUDAMED SRN
- IT-MF-000040989
Sources (2)
- EUDAMED 254e9b7f-5efd-4b25-bfba-c2c45cbfe2a7 61 fields · synced Jul 14, 2026
- EUDAMED 254e9b7f-5efd-4b25-bfba-c2c45cbfe2a7-1 61 fields · synced Jun 10, 2026