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Neonatal Phenylalanine
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref NP-1000
by Wallac Oy
Identity
- Trade Name
- Neonatal Phenylalanine EUDAMEDNeonatal Phenylalanine kit FDA UDI
- Generic Name
- Phenylalanine IVD, kit, fluorimetry FDA UDI
- Device Name
- Neonatal Phenylalanine EUDAMEDFor the quantitative determination of phenylalanine in dried blood. FDA UDI
- Model / Reference
- NP-1000 EUDAMEDFDA UDI
- Description
- For the quantitative determination of phenylalanine in dried blood. FDA UDI
Identifiers
- Catalog Number
- NP-1000 FDA UDI
- Primary DI / UDI-DI
- 06438147001286 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147001286 EUDAMED
- 510(k) Number
- K943547 FDA UDI
- FDA Product Code
- JNB FDA UDI
- EMDN Code
- W01010236 PHENYLKETONURIA EUDAMED
- GMDN Term
- Phenylalanine IVD, kit, fluorimetry FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1555 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Neonatal Phenylalanine by Wallac Oy — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438147001286 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED c8f12e7d-9064-4b58-ad34-33831a5d1cc9 61 fields · synced Jul 27, 2026
- FDA UDI a81716b2-4698-42f7-a9d4-fff1ae1e9d30 36 fields · synced May 29, 2026