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Ecg Roll 50mm X 20m
EUDAMEDClass I (EU MDR)
Ref ACC-5020/16R3Model Accu-PlusRef SK-5020/16R3Model SKYMEDRef SK-5020/16R4Ref SK-5020-16R4Ref SK-5020-16R3Ref APP-5020-16R4Model ALPHA-PLUSRef APP-5020-16R3
Identity
- Trade Name
- ECG ROLL 50MM X 20M EUDAMEDECG ROLL (50mm X 20m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-5020/16R3 EUDAMEDSKYMED EUDAMEDSK-5020/16R3 EUDAMEDSK-5020/16R4 EUDAMEDSK-5020-16R4 EUDAMEDSK-5020-16R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-5020-16R4 EUDAMEDAPP-5020-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812791 EUDAMED09551019811206 EUDAMED09551019810445 EUDAMED09551026272540 EUDAMED09551026272533 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019812791 EUDAMED09551019811206 EUDAMED09551019810445 EUDAMED09551026272540 EUDAMED09551026272533 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 20m 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 (7)
- EUDAMED 3a8a488b-83ea-4fe7-9031-0dfc56859098 61 fields · synced Sep 18, 2026
- EUDAMED 3693223d-e31c-4aef-ab7b-7d52ff422db0 61 fields · synced May 17, 2026
- EUDAMED 41a87aaa-bf2a-41f8-bf1d-5e9823b6ddeb 61 fields · synced May 19, 2026
- EUDAMED 3abe63a7-b308-4154-9fdb-a0dca3359155 61 fields · synced Jul 12, 2026
- EUDAMED c49675a6-fe63-4976-bba2-9411f9f83d63 61 fields · synced Jul 13, 2026
- EUDAMED 9ec0bbcf-3040-4e36-8267-2cc197c44a00 61 fields · synced Jul 13, 2026
- EUDAMED f918ca43-315e-44ff-b0c3-fe565cad243e 61 fields · synced Sep 18, 2026