Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06971792050037
- Basic UDI-DI Code
- B-06971792050037
- Reference
- K601416D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
This kit is intended for the qualitative detection the N protein of SARS-CoV-2 antigens in human anterior nasal swab specimens from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection. It is used for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/025/W/E.1 | CeCert Sp. z o.o. | Expired |
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