Identity
- Trade Name
- Ikaros EUDAMED
- Device Name
- Ikaros EUDAMED
- Model / Reference
- 7.0 EUDAMEDIkaros EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250406450015 EUDAMED
- Basic UDI-DI
- 42504064IKAROSBY EUDAMED
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Ikaros by MetaSystems Hard & Software GmbH — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940240 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 42504064IKAROSBY | Class A | Active |
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Manufacturer
- Manufacturer
- MetaSystems Hard & Software GmbH
- EUDAMED SRN
- DE-MF-000016548
- FDA Applicant
- Metasystems GmbH
Sources (2)
- EUDAMED b9bcc8c8-8465-47d1-bf3c-1dc42e371900 85 fields · synced Jun 18, 2026
- FDA 510(k) K940240 1 fields · synced May 18, 2026