Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05060654860417
- Basic UDI-DI Code
- 506065486GS-002Y2
- Reference
- GS-002
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Genedrive Diagnostics Ltd.
Additional Description
The Genedrive® System is an automated system used for qualitative in vitro molecular diagnostic tests. The system allows trained healthcare professionals to perform tests using single-use disposable cartridges, view results on an instrument touch screen and to export the results. The Genedrive® System is intended to be used by healthcare professionals within a near patient setting.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02050301 | NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).
Automatic Tissue Processor
Device
EU IVDR
·
Eu Ivd Class A
·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries
CELL COUNTING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Zhuji Zhiwei Information and Technology Ltd.·On the market
Magnetic Immunoassay System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen BOSH Diagnostics, Ltd.·On the market
ReaScan+
Device
EU IVDR
·
Eu Ivd Class A
·Reagena Oy·On the market·32 countries
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market