Basic UDI-DI
Eu Ivdd
Eu Ivd Self Testing
🇨🇳 China
SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)
Code: B-06974473306577
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
3
Basic Information
- UDI-DI Code
- B-06974473306577
- Issuing Agency
- EUDAMED
- Device Model
- RQ00501001HK
- Types
-
Kit Self testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Self Testing
- Manufacturer
- Nanjing Synthgene Medical Technology Co., Ltd.
- Last Updated
- August 24, 2022
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-173/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method) | On the market |