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ECG ROLL (50mm X 45m)
EUDAMEDClass I (EU MDR)
Ref SK-5045/16R4Model SKYMEDRef ACC-5045/16R4Model Accu-PlusRef APP-5045-16R3Model ALPHA-PLUSRef APP-5045-16R4
Identity
- Trade Name
- ECG ROLL (50mm X 45m) EUDAMEDECG ROLL 50MM X 45M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5045/16R4 EUDAMEDAccu-Plus EUDAMEDACC-5045/16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-5045-16R3 EUDAMEDAPP-5045-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811251 EUDAMED09551019812845 EUDAMED09551026272663 EUDAMED09551026272670 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811251 EUDAMED09551019812845 EUDAMED09551026272663 EUDAMED09551026272670 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 45m) 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 (4)
- EUDAMED e4b1b233-3c72-4866-83c6-3f9910758d12 61 fields · synced Sep 17, 2026
- EUDAMED bce7a6af-1bc8-49d6-b22c-68cc2849f9dc 61 fields · synced May 19, 2026
- EUDAMED 1e123e00-3ce7-4284-9ee4-bee16e93614c 61 fields · synced Jul 11, 2026
- EUDAMED 4837f67d-693a-4212-94e9-772ad56ca7bd 61 fields · synced Aug 4, 2026