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Eonis SCID-SMA kit
EUDAMEDClass IVD General (EU MDR)
Ref 3241-0020
by Wallac Oy
Identity
- Trade Name
- Eonis SCID-SMA kit EUDAMED
- Device Name
- Eonis SCD-SMA kit EUDAMEDEonis SCID-SMA kit EUDAMED
- Model / Reference
- 3241-0020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147388240 EUDAMED
- Basic UDI-DI
- B-06438147388240 EUDAMED6438147Eonis_SCID-SMA62 EUDAMED
- EMDN Code
- W0106010299 POLYGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
The Eonis SCID-SMA kit is a medical device designed for the detection and measurement of endotoxins, particularly from contaminated materials. The device uses a combination of enzymatic assays and fluorescence detection to provide accurate and reliable results.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06438147388240 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147388240 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 30d65fbe-0d9c-4b7a-909e-07f51537db66 61 fields · synced Jul 23, 2026
- EUDAMED fb41de42-1196-4266-9be7-4044e4a7c6b7 61 fields · synced May 17, 2026