Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List A
π¨π³ China
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Code: B-06955792731134
Devices
1
Certificates
2
Notified Bodies
2
Auth. Representatives
3
Basic Information
- UDI-DI Code
- B-06955792731134
- Issuing Agency
- EUDAMED
- Types
-
Kit Microbial substances Professional testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List A
- Manufacturer
- Sansure Biotech Inc.
- Last Updated
- February 24, 2025
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CeCert/116/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |
| IVDD Annex IV Section 4 | CeCert/115/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) | On the market |