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ECG ROLL (215mm X 25m)
EUDAMEDClass I (EU MDR)
Ref SK-21525/16R4Model SKYMEDRef SK-21525/16R3Ref ACC-21525/16R3Model Accu-PlusRef SK-21525-16R3Ref SK-21525-16R4
Identity
- Trade Name
- ECG ROLL (215mm X 25m) EUDAMEDECG ROLL 215MM X 25M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-21525/16R4 EUDAMEDSK-21525/16R3 EUDAMEDAccu-Plus EUDAMEDACC-21525/16R3 EUDAMEDSK-21525-16R3 EUDAMEDSK-21525-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811558 EUDAMED09551019811541 EUDAMED09551019813149 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019811558 EUDAMED09551019811541 EUDAMED09551019813149 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 (215mm 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-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 (5)
- EUDAMED 7c7758dc-da58-4172-b128-8655a3ec4459 61 fields · synced Sep 18, 2026
- EUDAMED 3c4ef600-59ac-4459-ae3c-df4504fab010 61 fields · synced May 17, 2026
- EUDAMED 2fe21eef-ddcb-4c8a-a995-cf84acc5fd4f 61 fields · synced May 19, 2026
- EUDAMED f68422ed-9ea9-43af-8a5e-1dc0cf26a2fe 61 fields · synced Jun 20, 2026
- EUDAMED 9198586d-a23e-475f-9342-663aa63c0e34 61 fields · synced Sep 18, 2026