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Phenylalanine (PKU) neonatal Screening Assay
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref RE80019
Identity
- Trade Name
- Phenylalanine (PKU) neonatal Screening Assay EUDAMED
- Device Name
- Phenylalanine (PKU) neonatal Screening Assay EUDAMED
- Model / Reference
- RE80019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325004573 EUDAMED
- Basic UDI-DI
- B-04049325004573 EUDAMED
- EMDN Code
- W01010236 PHENYLKETONURIA EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Phenylalanine (PKU) neonatal Screening Assay by Ibl International Gmbh — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04049325004573 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (1)
- EUDAMED 210797b8-f6db-45b1-94c3-d47eb41364f5 61 fields · synced Jul 27, 2026