Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
π¨π³ China
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 06955792731134
- Basic UDI-DI Code
- B-06955792731134
- Reference
- S3118E-48
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Sansure Biotech Inc.
Additional Description
This product is manufactured by Sansure Biotech Inc..
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020216 | HEPATITIS B VIRUS - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CeCert/116/W/E.1 | CeCert Sp. z o.o. | Expired |
| IVDD Annex IV Section 4 | CeCert/115/W/E.1 | CeCert Sp. z o.o. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).
Multiple Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market