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CardioLight+
EUDAMEDClass IIa (EU MDR)
Ref 05190100014Model CardioLight+Ref 05190100013Ref 05190100011
Identity
- Trade Name
- CardioLight+ EUDAMED
- Device Name
- Cardios Digital Holter Recorder EUDAMED
- Model / Reference
- CardioLight+ EUDAMED05190100014 EUDAMED05190100013 EUDAMED05190100011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00051901000149 EUDAMED00051901000132 EUDAMED00051901000118 EUDAMED
- Basic UDI-DI
- 78989943936CardioLight+3T EUDAMED
- Direct Marketing DI
- 00051901000149 EUDAMED00051901000132 EUDAMED00051901000118 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDSpain EUDAMEDIreland 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
CardioLight+ 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 | 78989943936CardioLight+3T | 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 (3)
- EUDAMED 20ec6494-ef01-481a-be3e-5127f95db2ae 61 fields · synced Jul 20, 2026
- EUDAMED 882d3923-c1f6-4033-9d9d-cfae3f6aaf7b 61 fields · synced May 17, 2026
- EUDAMED e57e92ad-afc2-4218-830b-eb0d295ebcac 61 fields · synced May 18, 2026