Devices (same UDI-DI)
1
Certificates
0
Countries
7
Notified Bodies
0
Basic Information
- Primary DI
- 07350128680015
- Basic UDI-DI Code
- 735012868003AS
- Reference
- PC10-003
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- PolarCool AB
Additional Description
The PolarCap System consists of an energy control unit (SmallCool) to which a soft and tight-fitting patient cooling pad covering the scalp and the neck is connected (PolarCap). The SmallCool pushes temperature-controlled PC Coolant through the PolarCap. This results in heat exchange between the PolarCap and the patient’s skin. PC Coolant temperature is controlled by a thermostat and its temperature probe. The PolarCap System maintains a controlled PC Coolant temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted by the system.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V9099 | VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER |
Available In Countries
🇩🇪 Germany
🇩🇰 Denmark
🇫🇮 Finland
🇫🇷 France
🇳🇴 Norway
🇸🇪 Sweden
🇬🇧 United Kingdom
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