Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPIOLAX MEDICAL DEVICES, INC.
Japan·JP-MF-000007059
Last updated September 17, 2026
Information
- Country
- Japan
- Address
- 2265-3, Kamiyabe-cho, Totsuka-ku, Yokohama-shi, Kanagawa, Japan
- Website
- www.piolax-md.co.jp/en/
- —
- —
- [email protected]
- Phone
- +81455489888
- PRRC Contact
- Kenji Inoue
- EUDAMED SRN
- JP-MF-000007059
- FDA FEI Number
- 3002917664
- DUNS Number
- —
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RevoWave PX | RWUA-2555I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWHA-3545I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWHJ-3545SJ | EUDAMEDFDA UDI | Class IIa | Active |
| Piolax Hydrophilic Guidewire | K980977 | FDA 510(k) | Class II | Active |
| RevoWave PX | RWHA-2545I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWHA-3526ID | EUDAMED | Class IIa | Active |
| RevoWave PX | RWHS-3526ID | EUDAMED | Class IIa | Active |
| RevoWave PX | RWSS-3555I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWHJ-2545SJ | EUDAMEDFDA UDI | Class IIa | Active |
| RevoWave PX | RWHS-3545I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWUS-2545S5A | EUDAMED | Class IIa | Active |
| RevoWave PX | RWSS-3526I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWHS-2545I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWUS-2555I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWSS-3545I | EUDAMED | Class IIa | Active |
| RevoWave PX | RWUA-2545F5A | EUDAMED | Class IIa | Active |
| RevoWave PX | RWSA-3545I | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Piolax Medical Devices, Inc. US