Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List B
🇺🇸 United States
Access Hybritech p2PSA (reagent pack)
Code: B-A49752W8
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
1
Basic Information
- UDI-DI Code
- B-A49752W8
- Issuing Agency
- EUDAMED
- Types
-
Animal tissues Human tissues Microbial substances Professional testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List B
- Manufacturer
- Beckman Coulter Inc.
- Last Updated
- June 13, 2022
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 668398 | BSI Group The Netherlands B.V. | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| Access Hybritech p2PSA (reagent pack) | On the market |