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ECG Roll (58mm x 30m)
EUDAMEDClass I (EU MDR)
Ref SK-5830/16R4Model SKYMEDRef SK-5830/16R3Ref ACC-5830/16R4Model Accu-PlusRef SK-5830-16R4Ref APP-5830-16R4Model ALPHA-PLUSRef SK-5830-16R3
Identity
- Trade Name
- ECG Roll (58mm x 30m) EUDAMEDECG ROLL 58MM X 30M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5830/16R4 EUDAMEDSK-5830/16R3 EUDAMEDAccu-Plus EUDAMEDACC-5830/16R4 EUDAMEDSK-5830-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-5830-16R4 EUDAMEDSK-5830-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811299 EUDAMED09551019811282 EUDAMED09551019812883 EUDAMED09551026272779 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811299 EUDAMED09551019811282 EUDAMED09551019812883 EUDAMED09551026272779 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 (58mm x 30m) 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 (6)
- EUDAMED b9471695-687a-4440-b93e-dfc765025776 61 fields · synced Jul 21, 2026
- EUDAMED 70ab773d-89f8-4529-9ccb-5c49658934ee 61 fields · synced May 18, 2026
- EUDAMED 55a76ebe-4de3-405f-93a9-ee641fa18799 61 fields · synced May 18, 2026
- EUDAMED 59cf97cd-b068-415f-b2d0-161eeb40aba8 61 fields · synced Jun 19, 2026
- EUDAMED cc342cac-5e1e-4932-a05f-7db99b01ba0c 61 fields · synced Jul 14, 2026
- EUDAMED a84e1345-933f-4af2-a91d-f8367c47c2f4 61 fields · synced Jul 21, 2026