Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List A
🇸🇬 Singapore
Sentosa SQ HCV Genotyping Assay (4x16)
Code: B-08885013956603
Devices
1
Certificates
2
Notified Bodies
2
Auth. Representatives
1
Basic Information
- UDI-DI Code
- B-08885013956603
- Issuing Agency
- EUDAMED
- Device Model
- 690018
- Types
-
Kit Microbial substances Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List A
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Last Updated
- November 08, 2023
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2074998-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |
| IVDD Annex IV Section 4 | IL 2074998-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| Sentosa SQ HCV Genotyping Assay Bundle (4x16) | On the market |