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Sign in to claim this brandWhat PAXMAN COOLERS LIMITED makes
Paxman Coolers Limited manufactures scalp cooling systems designed to reduce hair loss during chemotherapy. Their portfolio includes cooling caps, coolant solutions, and associated cap kits, all intended for use in clinical settings to help preserve hair during cancer treatment.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Paxman Coolers Limited manufacture?
Paxman Coolers Limited specializes in scalp cooling systems aimed at reducing hair loss during chemotherapy. Their product range includes cooling caps, coolant solutions (such as PSCS Coolant), and cap kits, all designed to help preserve hair for patients undergoing cancer treatment. These devices are specifically intended for clinical use.
Where is Paxman Coolers Limited based?
Paxman Coolers Limited is based in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as its devices are subject to FDA regulations.
Which regulatory registries list Paxman Coolers Limited’s devices?
Paxman Coolers Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Paxman Coolers Limited’s devices classified under FDA regulations?
Paxman Coolers Limited’s scalp cooling systems fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- paxmanusa.com
- —
- —
- [email protected]
- Phone
- 844-572-9626
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 519917264
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paxman Cooling Cap | Medium | FDA UDI | Class II | Active |
| Paxman Cooling Cap | Medium/Small | FDA UDI | Class II | Active |
| Paxman Cooling Cap | Large Asian | FDA UDI | Class II | Active |
| PSCS Coolant | 1L | FDA UDI | Class II | Active |
| PSCS Coolant | Coolant Batch | FDA UDI | Class II | Active |
| Paxman Accessories | Accessories Pack | FDA UDI | Class II | Unknown |
| Paxman cap kit | Medium, 25 credits | FDA UDI | Class II | Active |
| Paxman Cooling Cap | Small | FDA UDI | Class II | Active |
| Paxman Cooling cap | Sizing pack | FDA UDI | Class II | Active |
| Paxman Cooling Cap | Medium Asian | FDA UDI | Class II | Active |
| Paxman Cooling cap | Cap Batch | FDA UDI | Class II | Active |
| Paxman cap kit | Small, 25 credits | FDA UDI | Class II | Active |
| Paxman cap kit | Small Asian, 25 credits | FDA UDI | Class II | Active |
| Paxman cap kit | Large Asian, 25 credits | FDA UDI | Class II | Active |
| Paxman Cooling Cap | Large | FDA UDI | Class II | Active |
| Paxman Cooling cap | Sizing pack Asian | FDA UDI | Class II | Active |
| Pscs | 1 | FDA UDI | Class II | Active |
| Paxman cap kit | Large, 25 credits | FDA UDI | Class II | Active |
| Paxman cap kit | Medium/Small, 25 credits | FDA UDI | Class II | Active |
| PSCS Coolant | 3L | FDA UDI | Class II | Active |
| Pscs | 2 | FDA UDI | Class II | Active |
| Paxman cap kit | Medium Asian, 25 credits | FDA UDI | Class II | Active |
| PSCS Coolant | Comm Pack | FDA UDI | Class II | Active |
| Paxman Cooling Cap | Small Asian | FDA UDI | Class II | Active |
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