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Sign in to claim this brandWhat PIOLAX MEDICAL DEVICES, INC. makes
Piolax Medical Devices, Inc. manufactures single-use gastro-urological guidewires, including the RevoWave™ series, designed for procedural support in gastrointestinal and urological interventions.
The company’s products are classified as Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Piolax Medical Devices, Inc. manufacture?
Piolax Medical Devices, Inc. specializes in single-use gastro-urological guidewires. These devices are primarily used to assist in procedures within the gastrointestinal and urological systems, such as endoscopy or catheterization. The company’s focus is on the RevoWave™ series, which falls under this category.
Where is Piolax Medical Devices, Inc. based?
Piolax Medical Devices, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for U.S.-based healthcare providers.
How are Piolax Medical Devices, Inc.’s devices classified under FDA regulations?
Piolax Medical Devices, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to products that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as design controls, labeling requirements, and post-market surveillance.
Are Piolax Medical Devices, Inc.’s devices listed in any regulatory registries?
Yes, Piolax Medical Devices, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 693961984
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RevoWave™ | RWSS-3545I | FDA UDI | Class II | Active |
| RevoWave™ | RWHS-2545I | FDA UDI | Class II | Active |
| RevoWave™ | RWSA-3526I | FDA UDI | Class II | Active |
| RevoWave™ | RWHS-3545I | FDA UDI | Class II | Active |
| RevoWave™ | RWSS-3526I | FDA UDI | Class II | Active |
| RevoWave™ | RWUS-2555I | FDA UDI | Class II | Active |
| RevoWave™ | RWHA-2545I | FDA UDI | Class II | Active |
| RevoWave™ | RWHA-3526ID | FDA UDI | Class II | Active |
| RevoWave™ | RWUA-3545P | FDA UDI | Class II | Active |
| RevoWave™ | RWHA-3545I | FDA UDI | Class II | Active |
| RevoWave™ | RWHS-3526ID | FDA UDI | Class II | Active |
| RevoWave™ | RWSS-3555I | FDA UDI | Class II | Active |
| RevoWave™ | RWHA-2526ID | FDA UDI | Class II | Active |
| RevoWave™ | RWSA-3555I | FDA UDI | Class II | Active |
| RevoWave™ | RWSA-3545I | FDA UDI | Class II | Active |
| RevoWave™ | RWHS-2526ID | FDA UDI | Class II | Active |
| RevoWave™ | RWUA-2555I | FDA UDI | Class II | Active |
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