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Cardiette / Cardioline 200s/200+
EUDAMEDClass I (EU MDR)
Ref SK-CA-210295-180RSModel SKYMEDRef ACC-CA100150/180RSModel Accu-PlusRef SK-CA210295-180RSRef APP-CA210295-180RSModel ALPHA-PLUSRef ACC-CA210295/180RS
Identity
- Trade Name
- CARDIETTE / CARDIOLINE 200S/200+ EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-CA-210295-180RS EUDAMEDAccu-Plus EUDAMEDACC-CA100150/180RS EUDAMEDSK-CA210295-180RS EUDAMEDALPHA-PLUS EUDAMEDAPP-CA210295-180RS EUDAMEDACC-CA210295/180RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812128 EUDAMED09551019813750 EUDAMED09551019818953 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019812128 EUDAMED09551019813750 EUDAMED09551019818953 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 200s/200+ 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 (5)
- EUDAMED 0456dd58-c33f-46b5-8379-a5e2d7549b15 61 fields · synced Aug 2, 2026
- EUDAMED 7019d248-d92b-4774-a5a8-21e65e7f6261 61 fields · synced May 19, 2026
- EUDAMED 444dcba4-133f-452d-ad0e-f5f0aaf0c6dc 61 fields · synced Jul 9, 2026
- EUDAMED 859bce51-40b9-4260-96e7-4206dee42ccd 61 fields · synced Jul 14, 2026
- EUDAMED 4b3e1f36-ec61-4925-a188-9224268ad482 61 fields · synced Aug 2, 2026