Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List A
🇨🇳 China
HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)
Code: B-06952999407510
Devices
1
Certificates
2
Notified Bodies
2
Auth. Representatives
1
Basic Information
- UDI-DI Code
- B-06952999407510
- Issuing Agency
- EUDAMED
- Device Model
- IHC-302
- Types
-
Animal tissues Kit Microbial substances Professional testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List A
- Manufacturer
- Abon Biopharm(Hangzhou) Co., Ltd
- Last Updated
- November 21, 2023
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. 11 0497 QS/NB | INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | May 26, 2025 | |
| IVDD Annex IV Section 4 | No. 11 0498 CN/NB | INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| HCV ANTIBODY -RT & POC | On the market |