Eu Mdd
Eu Md Class 2b
On The Market
๐ฉ๐ฐ Denmark
Hedia Diabetes Assistant
Devices (same UDI-DI)
1
Certificates
1
Countries
10
Notified Bodies
1
Basic Information
- Primary DI
- 05700002209535
- Basic UDI-DI Code
- B-05700002209535
- Reference
- 2.11.0
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Hedia ApS
Additional Description
Hedia Diabetes Assistant is a medical mobile application (standalone software) with no body contact, intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G11054380002 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ฆ๐น Austria
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ฌ๐ง United Kingdom
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviรงos Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country