Basic UDI-DI
Eu Ivdd
Eu Ivd Annex 2 List B
🇩🇪 Germany
Phenylalanine (PKU) neonatal Screening Assay
Code: B-04049325004559
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
0
Basic Information
- UDI-DI Code
- B-04049325004559
- Issuing Agency
- EUDAMED
- Types
-
Animal tissues Kit Human tissues Professional testing Reagent
- Regulation
- Eu Ivdd Legacy
- Classification
- Eu Ivd Annex 2 List B
- Manufacturer
- IBL International GmbH
- Last Updated
- April 28, 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Expired / Withdrawn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) | CE665104 | BSI Group The Netherlands B.V. | May 26, 2025 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| Phenylalanine (PKU) neonatal Screening Assay | On the market |