Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06974674894002
- Basic UDI-DI Code
- B-06974674894002
- Reference
- 18-02-0038
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
Additional Description
18-02-0038
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/086/W/E.1 | CeCert Sp. z o.o. | Expired |
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