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Cardiette / Cardioline 100s/100+
EUDAMEDClass I (EU MDR)
Ref SK-CA-100150-180RSModel SKYMEDRef SK-CA100150-180RSRef APP-CA100150-180RSModel ALPHA-PLUS
Identity
- Trade Name
- CARDIETTE / CARDIOLINE 100S/100+ EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-CA-100150-180RS EUDAMEDSK-CA100150-180RS EUDAMEDALPHA-PLUS EUDAMEDAPP-CA100150-180RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812111 EUDAMED09551019818878 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019812111 EUDAMED09551019818878 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 100s/100+ 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 (3)
- EUDAMED a3eda055-cf92-4b9f-b3af-e25aeb4cc0d9 61 fields · synced Oct 6, 2026
- EUDAMED afb630d2-757f-433f-8cf0-95589cef0941 61 fields · synced Jun 19, 2026
- EUDAMED dfe47fe1-88c9-46fd-81a2-109831c6eb12 61 fields · synced Jul 25, 2026