Identity
- Trade Name
- Harmonia B EUDAMED
- Device Name
- Mammography system EUDAMED
- Model / Reference
- HARMONIA EUDAMEDF0477E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04630193910723 EUDAMED
- Basic UDI-DI
- 463019391HARMONIAW9 EUDAMED
- Direct Marketing DI
- 04630193910723 EUDAMED
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Harmonia B by MEDICAL TECHNOLOGIES Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 463019391HARMONIAW9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDICAL TECHNOLOGIES Ltd
- EUDAMED SRN
- RU-MF-000020612
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 612a055c-5847-4f57-bf64-b8de6a0e976d 61 fields · synced Jun 18, 2026