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Ecg Roll 50mm X 30m
EUDAMEDClass I (EU MDR)
Ref ACC-5030/16R4Model Accu-PlusRef SK-5030/16R3Model SKYMEDRef SK-5030/16R4Ref ACC-5030/16R3Ref SK-5030-13R4Ref SK-5030-13R3Ref APP-5030-16GN4Model ALPHA-PLUSRef APP-5030-13R4Ref SK-5030-16R4Ref ACC-5030/13R3Ref ACC-5030/16GN3Ref ACC-5030/13R4Ref ACC-5030/16GN4
Identity
- Trade Name
- ECG ROLL 50MM X 30M EUDAMEDECG Roll (50mm x 30m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-5030/16R4 EUDAMEDSKYMED EUDAMEDSK-5030/16R3 EUDAMEDSK-5030/16R4 EUDAMEDACC-5030/16R3 EUDAMEDSK-5030-13R4 EUDAMEDSK-5030-13R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-5030-16GN4 EUDAMEDAPP-5030-13R4 EUDAMEDSK-5030-16R4 EUDAMEDACC-5030/13R3 EUDAMEDACC-5030/16GN3 EUDAMEDACC-5030/13R4 EUDAMEDACC-5030/16GN4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810926 EUDAMED09551019810384 EUDAMED09551019810476 EUDAMED09551019811008 EUDAMED09551019818151 EUDAMED09551019818144 EUDAMED09551026272632 EUDAMED09551026272588 EUDAMED09551019818120 EUDAMED09551019818274 EUDAMED09551019818137 EUDAMED09551019818281 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019810926 EUDAMED09551019810384 EUDAMED09551019810476 EUDAMED09551019811008 EUDAMED09551019818151 EUDAMED09551019818144 EUDAMED09551026272632 EUDAMED09551026272588 EUDAMED09551019818120 EUDAMED09551019818274 EUDAMED09551019818137 EUDAMED09551019818281 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 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-APNG | 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 (13)
- EUDAMED 26983a35-08c5-4a0f-bee4-873e69515193 61 fields · synced Oct 1, 2026
- EUDAMED 6d028a5a-7053-4bb7-b5c8-0a27ca009354 61 fields · synced May 17, 2026
- EUDAMED 2d3077b9-1efa-4e47-98ce-b60cbb22b793 61 fields · synced May 17, 2026
- EUDAMED 916864bc-3ed3-43c1-ad28-fccbae8cdec4 61 fields · synced May 17, 2026
- EUDAMED 026c85ea-4b0b-4821-9be9-ac124f60b436 61 fields · synced Jul 9, 2026
- EUDAMED fd080629-3fe0-4f20-90e2-54d6916acee2 61 fields · synced Jul 9, 2026
- EUDAMED fc67cfc9-e24d-43a6-a09d-61524cae7454 61 fields · synced Jul 14, 2026
- EUDAMED 5ea4232c-64e6-4045-8ef5-5feb92f22dc7 61 fields · synced Jul 24, 2026
- EUDAMED 716391e9-79d6-4bda-a7a5-054a68e33506 61 fields · synced Jul 27, 2026
- EUDAMED f8ba9afc-8b64-4ded-8632-328a533e92f7 61 fields · synced Aug 2, 2026
- EUDAMED 94005ef3-818a-4154-858b-26bbd7d97f29 61 fields · synced Aug 2, 2026
- EUDAMED 4474ae87-e383-4699-b023-b899c2f67bb5 61 fields · synced Aug 4, 2026
- EUDAMED 387936ed-a3c2-4387-8560-a464ca075d9e 61 fields · synced Oct 1, 2026