Identity
- Device Name
- Heart Failure Analysis solution EUDAMED
- Model / Reference
- IM005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IM005U4 EUDAMED
- Basic UDI-DI
- B-IM005U4 EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heart Failure Analysis solution by Implicity — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-IM005U4 | Class I | Active |
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Manufacturer
- Manufacturer
- Implicity
- EUDAMED SRN
- FR-MF-000014184
Sources (1)
- EUDAMED bdb1e0c9-4aad-45ff-bea3-a909727ee86f 61 fields · synced Jul 11, 2026