Eu Ivdd
Eu Ivd Self Testing
On The Market
๐จ๐ณ China
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
14
Notified Bodies
1
Basic Information
- Primary DI
- 06974108068818
- Basic UDI-DI Code
- B-06974108068818
- Reference
- N/A
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- New Gene (Hangzhou) Bioengineering Co., Ltd.
Additional Description
This product is suitable for people with symptoms similar to COVID-19, like cough, fever, fatigue and etc., to assist the early diagnosis of SARS-CoV-2 infection. It can also be used to test people without COVID-19 symptoms to regularly monitor their health status.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-476/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
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