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DELFIA Neonatal hTSH Ultra kit
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref A042-201510(k) K923401
by Wallac Oy
Identity
- Trade Name
- DELFIA Neonatal hTSH Ultra kit EUDAMED
- Device Name
- DELFIA Neonatal hTSH Ultra kit EUDAMED
- Model / Reference
- A042-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147009213 EUDAMED
- Basic UDI-DI
- B-06438147009213 EUDAMED
- EMDN Code
- W01020403 NEONATAL THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
DELFIA Neonatal hTSH Ultra kit by Wallac Oy — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923401 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147009213 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 7174594b-b693-4084-91c1-7001c4da2bbe 85 fields · synced Jun 18, 2026
- FDA 510(k) K923401 1 fields · synced May 18, 2026