Eu Mdd
Eu Md Class 2b
On The Market
๐บ๐ธ United States
The Omnipod DASH Insulin Management System
Devices (same UDI-DI)
1
Certificates
1
Countries
17
Notified Bodies
1
Basic Information
- Primary DI
- 20385082000181
- Basic UDI-DI Code
- B-20385082000181
- Reference
- PT-000010 mg/dL and PT-000011 mmol/L
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Insulet Corporation
Additional Description
DASH Starterkit in mg/dL and in mmol/L
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120402160103 | PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 612985 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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