Identity
- Trade Name
- Diagnostic Suite EUDAMED
- Device Name
- Diagnostic Suite EUDAMED
- Model / Reference
- 1.y.z EUDAMEDV.1.y.z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860014963759 EUDAMED
- Basic UDI-DI
- 08600149637DxSVW EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Diagnostic Suite by Deephealth — Class I — 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 | 08600149637DxSVW | Class I | Active |
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Manufacturer
- Manufacturer
- DeepHealth, Inc.
- EUDAMED SRN
- US-MF-000051664
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED fb8648f6-4b23-4384-b27e-d2ebf960af2d 61 fields · synced Jun 19, 2026