Identity
- Trade Name
- CS System 4 EUDAMED
- Device Name
- CS System 4 EUDAMED
- Model / Reference
- CS-FG0015BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290018223017 EUDAMED
- Basic UDI-DI
- 7290018223017WJ EUDAMED
- Direct Marketing DI
- 07290018223017 EUDAMED
- EMDN Code
- Z12050801 COMPLETE CARDIAC TELEMETRY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CS System 4 by CardiacSense Ltd. — 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 | 7290018223017WJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- CardiacSense Ltd.
- EUDAMED SRN
- IL-MF-000014166
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED ecabb784-b7ab-4cc4-a89c-2aca27b24d15 61 fields · synced Jun 19, 2026