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ECG Roll (80mm x 20m)
EUDAMEDClass I (EU MDR)
Ref SK-8020/13R3Model SKYMEDRef SK-8020/13R4Ref SK-8020-13R4Ref SK-8020-16R4Ref APP-8020-13R3Model ALPHA-PLUSRef SK-8020-16R3Ref APP-8020-16R4Ref SK-8020-13R3Ref APP-8020-16R3Ref APP-8020-13R4
Identity
- Trade Name
- ECG Roll (80mm x 20m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-8020/13R3 EUDAMEDSK-8020/13R4 EUDAMEDSK-8020-13R4 EUDAMEDSK-8020-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-8020-13R3 EUDAMEDSK-8020-16R3 EUDAMEDAPP-8020-16R4 EUDAMEDSK-8020-13R3 EUDAMEDAPP-8020-16R3 EUDAMEDAPP-8020-13R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810391 EUDAMED09551019811343 EUDAMED09551019817659 EUDAMED09551026272939 EUDAMED09551019817642 EUDAMED09551026272960 EUDAMED09551026272953 EUDAMED09551026272946 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019810391 EUDAMED09551019811343 EUDAMED09551019817659 EUDAMED09551026272939 EUDAMED09551019817642 EUDAMED09551026272960 EUDAMED09551026272953 EUDAMED09551026272946 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
ECG Roll (80mm x 20m) 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 (10)
- EUDAMED e5fa0c17-e3fa-4b53-98a7-ab93a1e46ffa 61 fields · synced Aug 4, 2026
- EUDAMED 2a91c6d5-cacd-4a7e-aba7-55579bacf3b4 61 fields · synced May 19, 2026
- EUDAMED 62a19a91-10f6-4783-b83c-7736180cd56d 61 fields · synced Jul 9, 2026
- EUDAMED d31569e2-6d60-417b-a1c3-8fc69b9e3e8e 61 fields · synced Jul 11, 2026
- EUDAMED b36db6d2-9446-4937-9242-a80552ede691 61 fields · synced Jul 11, 2026
- EUDAMED 9b7201e4-fb94-4f71-80a2-116cb2d1acd6 61 fields · synced Jul 22, 2026
- EUDAMED e45f8fd8-0cd6-4170-bf18-cf7125ec4562 61 fields · synced Jul 31, 2026
- EUDAMED 661dd49c-04b9-4bf2-915b-caedfaef0816 61 fields · synced Aug 2, 2026
- EUDAMED 90931d58-f6c5-4ecc-8fea-895d6521c495 61 fields · synced Aug 2, 2026
- EUDAMED ff4f576c-8598-4d50-9113-7a7b91758fb5 61 fields · synced Aug 4, 2026