Eu Mdd
Eu Md Class 1
On The Market
๐ซ๐ฎ Finland
Balansio
Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
Basic Information
- Primary DI
- D-FI-MF-000009237-32U
- Basic UDI-DI Code
- B-FI-MF-000009237-32U
- Reference
- D-FI-MF-000009237-32U
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- ProWellness Health Solutions Oy
Additional Description
The product is a software intended for collecting and aggregating a user's selfcare data for enabling communication between the user and a healthcare professional, to facilitate the user's self-care. The product captures home measurements (e.g., blood pressure, weight, and blood glucose), nutritional and exercising information, and medication information, and provides messaging functionalities. The product is not intended for diagnosing, treating, or alleviating a disease, injury or handicap.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z129082 | VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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