Eu Ivdr
Eu Ivd Class A
On The Market
๐ง๐ช Belgium
BlueDiver Instrument
Devices (same UDI-DI)
1
Certificates
0
Countries
18
Notified Bodies
0
Basic Information
- Primary DI
- 05425023685006
- Basic UDI-DI Code
- 5425023685006VX
- Reference
- BLUEDIVER1
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- D-tek s.a.
Additional Description
Semi-automated ImmunoAssay Instrument dedicated to the carrying out of in vitro diagnosis tests. It performs the various steps of incubation and washing of D-tekโs immunodot strips and other kits with equivalent BlueDiver Design (strips and cartridges), from the deposit of the sample to the final colour development. The BlueDiver Instrument is intended only for laboratory professional use and must be used only by trained personnel.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020101 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
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