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Cardiette / Cardioline 874 5554
EUDAMEDClass I (EU MDR)
Ref SK-CA-112100-300RSModel SKYMEDRef APP-CA112100-300RSModel ALPHA-PLUS
Identity
- Trade Name
- CARDIETTE / CARDIOLINE 874 5554 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-CA-112100-300RS EUDAMEDALPHA-PLUS EUDAMEDAPP-CA112100-300RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812104 EUDAMED09551019818885 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019812104 EUDAMED09551019818885 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
Category: Electrocardiographic lead set, reusable
Cardiette / Cardioline 874 5554 by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- 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 | 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 (2)
- EUDAMED ae844daa-3eb9-490a-808f-ec3b66f68648 61 fields · synced Oct 6, 2026
- EUDAMED daeafe27-4c3c-4aa9-b062-f4eabeb5ccc0 61 fields · synced Jul 22, 2026