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Neonatal Phenylalanine Calibrators
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 6190940
Identity
- Trade Name
- Neonatal Phenylalanine Calibrators EUDAMED
- Device Name
- Neonatal Phenylalanine Calibrators EUDAMED
- Model / Reference
- 6190940 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172194014 EUDAMED
- Basic UDI-DI
- B-06438172194014 EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Neonatal Phenylalanine Calibrators by Labsystems Diagnostics Oy — 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-06438172194014 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED acd406b5-c32e-423f-9b4b-9c1f01c5928b 61 fields · synced Jun 19, 2026