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ECG ROLL (50mm X 40m)
EUDAMEDClass I (EU MDR)
Ref SK-5040/16R3Model SKYMEDRef ACC-5040/16R3Model Accu-PlusRef ACC-5040/16R4Ref SK-5040-16R3Ref APP-5040-16R3Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL (50mm X 40m) EUDAMEDECG ROLL 50MM X 40M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5040/16R3 EUDAMEDAccu-Plus EUDAMEDACC-5040/16R3 EUDAMEDACC-5040/16R4 EUDAMEDSK-5040-16R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-5040-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811220 EUDAMED09551019812814 EUDAMED09551019812821 EUDAMED09551026272649 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811220 EUDAMED09551019812814 EUDAMED09551019812821 EUDAMED09551026272649 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 (50mm X 40m) 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 99632fe4-4d34-465c-9f71-87448b376b63 61 fields · synced Sep 17, 2026
- EUDAMED 2675fcd3-2645-47af-81d2-fcaeec721a6f 61 fields · synced May 18, 2026
- EUDAMED a47c6a49-288f-4297-90ec-0f7b3096287f 61 fields · synced May 18, 2026
- EUDAMED 1cec0a61-7d6e-4569-84ec-e7f0ca526fc5 61 fields · synced Jun 19, 2026
- EUDAMED 6d8a0a12-6668-48d8-ba3d-8a009519a72f 61 fields · synced Jul 26, 2026