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Neonatal Total Galactose kit
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 3029-0010510(k) K071649
by Wallac Oy
Identity
- Trade Name
- Neonatal Total Galactose kit EUDAMEDFDA UDI
- Generic Name
- Total galactose IVD, kit, enzyme fluorescence FDA UDI
- Device Name
- Neonatal Total Galactose kit EUDAMEDFor the quantitative determination of galactose and galactose-1-phosphate in dried blood. Note: Kit contains multiple packages. FDA UDI
- Model / Reference
- 3029-0010 EUDAMEDFDA UDI
- Description
- For the quantitative determination of galactose and galactose-1-phosphate in dried blood. Note: Kit contains multiple packages. FDA UDI
Identifiers
- Catalog Number
- 3029-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147275281 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147275281 EUDAMED
- 510(k) Number
- K071649 FDA UDI
- FDA Product Code
- JIA FDA UDI
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
- GMDN Term
- Total galactose IVD, kit, enzyme fluorescence FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1310 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
Yes
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 Total Galactose kit by Wallac Oy — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, 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 | K071649 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147275281 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (3)
- EUDAMED faa0c0c9-3dcb-402c-b4f3-0971e19f2cc1 85 fields · synced Jun 18, 2026
- FDA UDI 239e4cd5-07d9-47f1-aebd-4018aedb61ad 36 fields · synced May 30, 2026
- FDA 510(k) K071649 1 fields · synced Jun 9, 2026