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Cardiette / Cardioline 660 100 37
EUDAMEDClass I (EU MDR)
Ref SK-CA-6015-16BS3Model SKYMEDRef ACC-CA6015/16BS3Model Accu-PlusRef APP-CA6015-16BS3Model ALPHA-PLUSRef SK-CA6015-16BS3
Identity
- Trade Name
- CARDIETTE / CARDIOLINE 660 100 37 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-CA-6015-16BS3 EUDAMEDAccu-Plus EUDAMEDACC-CA6015/16BS3 EUDAMEDALPHA-PLUS EUDAMEDAPP-CA6015-16BS3 EUDAMEDSK-CA6015-16BS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811992 EUDAMED09551019813637 EUDAMED09551019818977 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019811992 EUDAMED09551019813637 EUDAMED09551019818977 EUDAMED
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMEDZ12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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
Cardiette / Cardioline 660 100 37 by Isd Meditech Sdn. Bhd. — Class I — 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 | 955101981MCRP-SMPY | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED ad25970b-261f-47fa-9918-5778c4eb6012 61 fields · synced Oct 6, 2026
- EUDAMED c91f507c-8a00-4925-af51-18fc8de5093c 61 fields · synced May 19, 2026
- EUDAMED 1787aaa0-2fc9-47a0-bcf8-d5b867eb87d8 61 fields · synced Jul 9, 2026
- EUDAMED 912162bb-fa27-4d01-ab61-43487c1bccbb 61 fields · synced Jul 31, 2026