Identity
- Trade Name
- inHEART Models Explorer EUDAMED
- Device Name
- inHEART Models Explorer EUDAMED
- Model / Reference
- v3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019599105 EUDAMED
- Basic UDI-DI
- 3770019599Explorerv2P5 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa 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 Models Explorer by Inheart — Class IIa — 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 | 3770019599Explorerv2P5 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- inHEART
- EUDAMED SRN
- FR-MF-000006723
Sources (1)
- EUDAMED 8cd4baf2-e776-4494-98f0-2e07481e797c 61 fields · synced May 25, 2026