← Back to catalogue
GSP Neonatal Biotinidase kit
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref 3307-0010
by Wallac Oy
Identity
- Trade Name
- GSP Neonatal Biotinidase kit EUDAMED
- Device Name
- GSP Neonatal Biotinidase kit EUDAMED
- Model / Reference
- 3307-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147330904 EUDAMED
- Basic UDI-DI
- B-06438147330904 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland 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
GSP Neonatal Biotinidase 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 | K131284 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147330904 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 6b991e6a-069d-4a86-b55e-555d0df2f077 61 fields · synced Jul 19, 2026
- FDA 510(k) K131284 1 fields · synced May 18, 2026