Eu Mdd
Eu Md Class 2a
On The Market
🇰🇷 South Korea
INFUSION INSTRUMENTS - CONSUMABLES
Devices (same UDI-DI)
1
Certificates
1
Countries
7
Notified Bodies
1
Basic Information
- Primary DI
- 08809220580765
- Basic UDI-DI Code
- B-08809220580765
- Reference
- SD-300
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- SOOIL Development Co., Ltd.
Additional Description
The DANA 3cc Syringe Insulin Reservoir (“Syringe” and “Reservoir”) is a disposable, single-use, sterile, non-pyrogenic, syringe that is designed for use with all version of the DANA Diabecare Insulin Pump to infusion insulin. The reservoir is a 3ml syringe with a 300 units insulin capacity and consisting of hollow barrel, movable plunger with O-rings for sealing, and 22G x 1/2“, 26mm straight needle for filling the reservoir from a medication vial.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030385 | INFUSION INSTRUMENTS - CONSUMABLES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | SD-300 | SGS Belgium NV | Expired |
Available In Countries
🇧🇬 Bulgaria
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇫🇷 France
🇮🇹 Italy
🇹🇷 Türkiye
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