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Cardiette / Cardioline 660 100 26
EUDAMEDClass I (EU MDR)
Ref ACC-CA13025/20BS3Model Accu-PlusRef APP-CA13025-20BS3Model ALPHA-PLUS
Identity
- Trade Name
- CARDIETTE / CARDIOLINE 660 100 26 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-CA13025/20BS3 EUDAMEDALPHA-PLUS EUDAMEDAPP-CA13025-20BS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813668 EUDAMED09551019818922 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019813668 EUDAMED09551019818922 EUDAMED
- EMDN Code
- Z12059009 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 26 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-APNG | 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 (2)
- EUDAMED 91ad7d5e-724a-43ef-ac04-c5e9fdb324d1 61 fields · synced Jul 12, 2026
- EUDAMED c28bc463-faaf-4e1c-b307-4959a4410596 61 fields · synced Jul 12, 2026