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Phenylalanine (Phe) Diagnostic Kit (Fluorometric Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DR-NS-A002Model 480 tests/kit
Identity
- Device Name
- Phenylalanine (Phe) Diagnostic Kit (Fluorometric Assay) EUDAMED
- Model / Reference
- 480 tests/kit EUDAMEDDR-NS-A002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974671100342 EUDAMED
- Basic UDI-DI
- B-06974671100342 EUDAMED
- EMDN Code
- W01010236 PHENYLKETONURIA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 (Phe) Diagnostic Kit (Fluorometric Assay) by Darui Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974671100342 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Darui Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030310
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 13fba573-d345-4b08-a82c-5d98b845a811 61 fields · synced Jun 19, 2026