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CardioSmart CS550 ES
EUDAMEDClass IIa (EU MDR)
Ref 05194000034Model CARDIOSMART CS550
Identity
- Trade Name
- CardioSmart CS550 ES EUDAMED
- Device Name
- CARDIOSMART CS550 HOLTER ANALYSIS SOFTWARE EUDAMED
- Model / Reference
- CARDIOSMART CS550 EUDAMED05194000034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00051940000346 EUDAMED
- Basic UDI-DI
- 78989943936CS550UB EUDAMED
- Direct Marketing DI
- 00051940000346 EUDAMED
- EMDN Code
- Z12050401 CARDIOVASCULAR HOLTER ANALYSERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CardioSmart CS550 ES by Cardio Sistemas Comercial e Industrial Ltda — 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 | 78989943936CS550UB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cardio Sistemas Comercial e Industrial Ltda
- EUDAMED SRN
- BR-MF-000024824
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b5387e9b-6af1-45a5-a0d3-4ebde63c89b9 61 fields · synced Jul 24, 2026