Identity
- Trade Name
- CardiacSense Medical Watch EUDAMED
- Device Name
- CS System 4 EUDAMED
- Model / Reference
- CS-FG0015BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290018223000 EUDAMED
- Basic UDI-DI
- 7290018223017WJ EUDAMED
- Direct Marketing DI
- 07290018223000 EUDAMED
- EMDN Code
- Z12050801 COMPLETE CARDIAC TELEMETRY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
CardiacSense Medical Watch 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 189baa0d-814d-442d-b770-6bf7c586cc67 61 fields · synced Jun 18, 2026