Eu Mdd
Eu Md Class 2a
On The Market
🇮🇱 Israel
ProSense Cryoablation System
Devices (same UDI-DI)
1
Certificates
1
Countries
11
Notified Bodies
1
Basic Information
- Primary DI
- 07290015487177
- Basic UDI-DI Code
- B-07290015487177
- Reference
- FAS3100000
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- IceCure Medical Ltd.
Additional Description
ProSense™ Cryoablation System is a comprehensive system that is used in conjunction with an Imaging System (for example, Ultrasound) for cryotherapy of human tissue based on IceCure™ Medical’s technology. All established cryotherapy techniques utilize a low temperature cryogen under pressure. The ProSense™ Cryoablation System utilizes Liquid Nitrogen that causes the cryoprobe to reach very low temperatures thereby freezing tissue with which it comes in contact.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120102 | CRYOSURGERY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 6555G410210511A | DNV MEDCERT GmbH | Expired |
Available In Countries
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇫🇷 France
🇭🇺 Hungary
🇮🇹 Italy
🇳🇱 Netherlands
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇹🇷 Türkiye
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