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Ecg Roll 108mm X 23m
EUDAMEDClass I (EU MDR)
Ref ACC-10823/16R3Model Accu-PlusRef ACC-10823/16R4Ref APP-10823-16R4Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL 108MM X 23M EUDAMEDECG ROLL (108MM X 23M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-10823/16R3 EUDAMEDACC-10823/16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-10823-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813002 EUDAMED09551019817734 EUDAMED09551026273097 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019813002 EUDAMED09551019817734 EUDAMED09551026273097 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 108mm X 23m 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 (3)
- EUDAMED 3b610218-45f0-483f-8534-898b8ba2d755 61 fields · synced Jul 26, 2026
- EUDAMED bba6bdcd-9bbd-4292-bf07-633d72d9fe9b 61 fields · synced Jul 19, 2026
- EUDAMED ec0ac8eb-6362-4eb5-8ded-81b69c3e5959 61 fields · synced Jul 26, 2026