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LifeCycle Risk Calculation Engine
EUDAMEDClass C (EU MDR)
Ref 5015-8001
by Wallac Oy
Identity
- Trade Name
- LifeCycle Risk Calculation Engine EUDAMED
- Device Name
- LifeCycle Risk Calculation Engine EUDAMED
- Model / Reference
- 5015-8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147407729 EUDAMED
- Basic UDI-DI
- 6438147LifeCycle_8RCEJ4 EUDAMED
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Special Device Type
- Software 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
No
EUDAMED
New Device
Yes
EUDAMED
LifeCycle Risk Calculation Engine by Wallac Oy — Class C — 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 | 6438147LifeCycle_8RCEJ4 | Class C | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (1)
- EUDAMED 14e034e5-9f9b-46bc-9b76-b10ad6abf51f 61 fields · synced Jul 10, 2026