Identity
- Trade Name
- Harmonia DBT EUDAMED
- Device Name
- Mammography system EUDAMED
- Model / Reference
- HARMONIA EUDAMEDF0479E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04630193910662 EUDAMED
- Basic UDI-DI
- 463019391HARMONIAW9 EUDAMED
- Direct Marketing DI
- 04630193910662 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 DBT 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 c3520e5e-ac89-48c3-8013-bf190006cbd5 61 fields · synced Jun 18, 2026