Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List B
🇨🇳 China
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test (Colloidal Gold)
Code: B-06935091671928
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
1
Basic Information
- UDI-DI Code
- B-06935091671928
- Issuing Agency
- EUDAMED
- Types
-
Kit Professional testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List B
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
- Last Updated
- February 17, 2025
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 093780 0004 | TÜV SÜD Product Service GmbH | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold) | On the market |