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Ecg Roll 100mm X 25m
EUDAMEDClass I (EU MDR)
Ref ACC-10025/16RS4Model Accu-PlusRef APP-10025-16RS4Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL 100MM X 25M EUDAMEDECG ROLL (100MM X 25M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-10025/16RS4 EUDAMEDALPHA-PLUS EUDAMEDAPP-10025-16RS4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812975 EUDAMED09551026273059 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019812975 EUDAMED09551026273059 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 100mm X 25m 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 (2)
- EUDAMED 578230c2-ee8f-4a13-8a28-ac1961d8a555 61 fields · synced Jul 9, 2026
- EUDAMED f7cc3862-7942-40c3-85e1-2d5c0534556e 61 fields · synced Jul 9, 2026