Identity
- Trade Name
- RevoWave PX EUDAMED
- Model / Reference
- RWSS-3555I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04545428039097 EUDAMED
- Basic UDI-DI
- B-04545428039097 EUDAMED
- EMDN Code
- G030499,G030899,U0601,V9018 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
RevoWave PX by Piolax Medical Devices, Inc. — 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-04545428039097 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Piolax Medical Devices, Inc.
- EUDAMED SRN
- JP-MF-000007059
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cff6c263-ca45-4604-9713-202cad876940 61 fields · synced Jun 19, 2026