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Sign in to claim this brandPEROUSE MEDICAL
US
Last updated May 23, 2026
What PEROUSE MEDICAL makes
Perouse Medical manufactures subcutaneous infusion and injection port needles, vascular ports and catheters, single-use needle guides, and catheter/overtube balloon inflators. Their portfolio includes devices like the POLYPERF SAFE, PPS PI, and Polysite, designed for medical procedures requiring secure access and controlled inflation.
The company’s products are regulated under FDA Class I and Class II classifications, with authorisation records maintained in the FDA’s 510(k) and UDI databases. These devices are listed under U.S. regulatory frameworks.
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 Perouse Medical primarily manufacture?
Perouse Medical specializes in devices for secure medical access and controlled inflation. Their portfolio includes subcutaneous infusion and injection port needles, vascular ports and catheters, single-use needle guides, and catheter/overtube balloon inflators. These products are designed to support procedures requiring precise and reliable access, such as chemotherapy, hydration, or diagnostic interventions.
Where is Perouse Medical based, and how does that affect its regulatory oversight?
Perouse Medical is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies their products as either Class I or Class II, depending on risk levels, with records of authorisation tracked in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device regulations.
Which regulatory registries list Perouse Medical’s devices, and why?
Perouse Medical’s devices are listed in the FDA’s 510(k) and UDI databases. The 510(k) registry tracks premarket submissions for devices deemed to be substantially equivalent to existing authorised products, while the UDI system standardizes device identification for traceability and safety monitoring. These registries help ensure transparency and compliance with U.S. medical device regulations.
How are Perouse Medical’s devices classified under FDA regulations?
Perouse Medical’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product.
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
- 267476323
Catalogue (112)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pps Pi | U211906 | FDA UDI | Class II | Active |
| Polyperf Safe | U111912 | FDA UDI | Class II | Active |
| Polyperf Safe | U101907 | FDA UDI | Class II | Active |
| Pps Pi | U212010 | FDA UDI | Class II | Active |
| Pps Pi | U202212 | FDA UDI | Class II | Active |
| Polyperf Safe | U112006 | FDA UDI | Class II | Active |
| Polysite | 2016PI | FDA UDI | Class II | Unknown |
| Dolphin | 0185ND | FDA UDI | Class II | Active |
| Inflation System | 03.804.413S | FDA UDI | Class I | Active |
| Seal One | K123035 | FDA 510(k) | Class II | Active |
| Pps Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, Pps Pi Pressure Injectable Safety Huber | K120261 | FDA 510(k) | Class II | Active |
| Polysite Implantable Infusion Ports | K122834 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Perouse Medical FRANCE Oise · FR FEI 3006942524