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RevoWave PX
EUDAMEDClass IIa (EU MDR)
Ref RWUS-2555IRef RWSA-3526IRef RWHS-2526IDRef RWUA-2545F2ARef RWSA-3555IRef RWUA-3545PRef RWHA-2526ID
Identity
- Trade Name
- RevoWave PX EUDAMED
- Model / Reference
- RWUS-2555I EUDAMEDRWSA-3526I EUDAMEDRWHS-2526ID EUDAMEDRWUA-2545F2A EUDAMEDRWSA-3555I EUDAMEDRWUA-3545P EUDAMEDRWHA-2526ID EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04545428039103 EUDAMED04545428039042 EUDAMED04545428039158 EUDAMED04545428038380 EUDAMED04545428039059 EUDAMED04545428039028 EUDAMED04545428039141 EUDAMED
- Basic UDI-DI
- B-04545428039103 EUDAMEDB-04545428039042 EUDAMEDB-04545428039158 EUDAMEDB-04545428038380 EUDAMEDB-04545428039059 EUDAMEDB-04545428039028 EUDAMEDB-04545428039141 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-04545428039103 | 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 (7)
- EUDAMED daae19ac-e655-43f5-bae7-d2967796d23e 61 fields · synced Aug 1, 2026
- EUDAMED c725a865-e6d6-4415-8993-00b6461eb35d 61 fields · synced May 17, 2026
- EUDAMED 0fc8c485-1881-4873-bdc0-b3db02bc3db2 61 fields · synced May 17, 2026
- EUDAMED 390e5d04-9997-49ed-a0f9-a8e3c73bc551 61 fields · synced May 18, 2026
- EUDAMED 6f2cff4c-420f-405e-b558-fc8c7ac1f783 61 fields · synced May 18, 2026
- EUDAMED 77b0632a-f00d-4dd0-9dd1-14838a033875 61 fields · synced May 19, 2026
- EUDAMED d13be129-d62b-4e7d-b207-0806aefb6a70 61 fields · synced May 19, 2026