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Armonicus
EUDAMEDClass IIb (EU MDR)
Ref 9785064100Model ArmonicusRef 9785065300Ref 9785064200Ref 9785063100
Identity
- Trade Name
- Armonicus EUDAMED
- Model / Reference
- Armonicus EUDAMED9785064100 EUDAMED9785065300 EUDAMED9785064200 EUDAMED9785063100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057737121746 EUDAMED08057737121784 EUDAMED08057737121753 EUDAMED08057737121715 EUDAMED
- Basic UDI-DI
- 805773712FT2529R EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Armonicus can be used for general radiographic examination, including undertable, tabletop and upright positioning of the Flat Panel Detector EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Armonicus by Villa Sistemi Medicali S.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805773712FT2529R | Class IIb | Active |
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Manufacturer
- Manufacturer
- Villa Sistemi Medicali S.p.A.
- EUDAMED SRN
- IT-PR-000027254
Sources (4)
- EUDAMED 7de667d1-d117-4b54-8779-fb03d87fb2e5 61 fields · synced Jul 31, 2026
- EUDAMED 44c53b55-9c45-46f3-b162-aa9b0fd61384 61 fields · synced May 17, 2026
- EUDAMED efe3da4a-8652-4970-9969-bb08661d7666 61 fields · synced May 18, 2026
- EUDAMED 2210dcc8-ac67-4f01-a81e-30e1e05f8407 61 fields · synced May 18, 2026