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Eonis SCID-SMA kit
EUDAMEDClass C (EU MDR)
Ref 3241-0010Ref 3242-0010
by Wallac Oy
Identity
- Trade Name
- Eonis SCID-SMA kit EUDAMED
- Device Name
- Eonis SCID-SMA kit EUDAMED
- Model / Reference
- 3241-0010 EUDAMED3242-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147377725 EUDAMED06438147377749 EUDAMED
- Basic UDI-DI
- 6438147Eonis_SCID-SMA62 EUDAMEDB-06438147377749 EUDAMEDB-06438147377725 EUDAMED
- EMDN Code
- W0106010299 POLYGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General 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
Eonis SCID-SMA kit by Wallac Oy — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438147Eonis_SCID-SMA62 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6438147Eonis_SCID-SMA62 | Class C | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (6)
- EUDAMED d0d8f658-1ceb-4432-ab3d-523578c07355 61 fields · synced Jul 15, 2026
- EUDAMED eb49f191-eacb-438d-a083-cdf1bfadae9c 61 fields · synced May 18, 2026
- EUDAMED a331e162-9944-4f07-8661-f45a8742f0be 61 fields · synced May 18, 2026
- EUDAMED 7a7aaef8-3ecc-45b7-9b65-43ed217a6d03 61 fields · synced May 19, 2026
- EUDAMED bda789ec-f5e0-47ae-ae13-898b352c0f77 61 fields · synced Jul 13, 2026
- EUDAMED bb2af76c-ac15-4d0b-a313-852cb2d29d01 61 fields · synced Jul 15, 2026