Identity
- Trade Name
- Eonis Q96 EUDAMED
- Device Name
- Eonis Q96 EUDAMED
- Model / Reference
- 2044-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147387700 EUDAMED
- Basic UDI-DI
- 6438147EonisQ_4J EUDAMED
- EMDN Code
- W02050180 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Eonis Q96 by Wallac Oy — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147EonisQ_4J | Class A | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (1)
- EUDAMED dad0d732-d22a-46cd-a720-a824f0957517 61 fields · synced Jun 17, 2026