Identity
- Trade Name
- inHEART Portal EUDAMED
- Device Name
- inHEART Portal EUDAMED
- Model / Reference
- v4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019599129 EUDAMED
- Basic UDI-DI
- 3770019599Portalv42J EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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
inHEART Portal by Inheart — 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 | 3770019599Portalv42J | Class I | Active |
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Manufacturer
- Manufacturer
- inHEART
- EUDAMED SRN
- FR-MF-000006723
Sources (1)
- EUDAMED 399c4b23-2e35-4b00-acae-e99663c0e085 61 fields · synced Jul 12, 2026