← Back to catalogue
Patient Cable CL 4 Leads
EUDAMEDClass IIa (EU MDR)
Ref 05195000013Model CardioLight+
Identity
- Trade Name
- Patient Cable CL 4 Leads EUDAMED
- Device Name
- Cardios Digital Holter Recorder EUDAMED
- Model / Reference
- CardioLight+ EUDAMED05195000013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00051950000138 EUDAMED
- Basic UDI-DI
- 78989943936CardioLight+3T EUDAMED
- EMDN Code
- Z12050480 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electrocardiographic lead set, reusable
Patient Cable CL 4 Leads by Cardio Sistemas Comercial e Industrial Ltda — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardio Sistemas Comercial e Industrial Ltda
- EUDAMED SRN
- BR-MF-000024824
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 4f12acad-f141-4cda-bf51-7a98a0610501 61 fields · synced Jul 25, 2026