Basic UDI-DI
Eu Ivdd
Eu Ivd Self Testing
🇩🇰 Denmark
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)
Code: B-05745000468140
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
0
Basic Information
- UDI-DI Code
- B-05745000468140
- Issuing Agency
- EUDAMED
- Device Model
- 1 test/kit
- Types
-
Kit Self testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Self Testing
- Manufacturer
- BGI EUROPE A/S
- Last Updated
- February 15, 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Expired / Withdrawn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-011/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| BGI | On the market |