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ECG ROLL (112mm X 25m)
EUDAMEDClass I (EU MDR)
Ref SK-11225/16R3Model SKYMEDRef ACC-11225/16R4Model Accu-PlusRef SK-11225-16R3
Identity
- Trade Name
- ECG ROLL (112mm X 25m) EUDAMEDECG ROLL 112MM X 25M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-11225/16R3 EUDAMEDAccu-Plus EUDAMEDACC-11225/16R4 EUDAMEDSK-11225-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811435 EUDAMED09551019817741 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019811435 EUDAMED09551019817741 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 (112mm 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 (3)
- EUDAMED 9b6ca7f8-9bfc-45b5-9510-6e9ae72b96ee 61 fields · synced Oct 6, 2026
- EUDAMED 55da13c5-ebde-400b-b050-1aa5a543af0b 61 fields · synced Jul 26, 2026
- EUDAMED 0bd9483d-d961-48c0-be3e-f4253eecc5e2 61 fields · synced Oct 6, 2026