Eu Mdd
Eu Md Class 2b
On The Market
๐ฐ๐ท South Korea
INFUSION PUMPS
Devices (same UDI-DI)
1
Certificates
1
Countries
8
Notified Bodies
1
Basic Information
- Primary DI
- 08809220582981
- Basic UDI-DI Code
- B-08809220582981
- Reference
- DANA Diabecare RS kit
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- SOOIL Development Co., Ltd.
Additional Description
The DANA Diabecare RS Insulin Pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The user-programmable device has two insulin delivery modes, the basal infusion rate and meal bolus doses. The user can also temporarily adjust the basal infusion rate to accommodate changes in activity levels, such as during exercise. The pump is battery-powered, water-resistant, very compact, and weighs only 62 grams.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030301 | INFUSION PUMPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | KR19/81826308 | SGS Belgium NV | Expired |
Available In Countries
๐ง๐ฌ Bulgaria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ซ๐ท France
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐น๐ท Tรผrkiye
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