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Ecg Roll 118mm X 30m
EUDAMEDClass I (EU MDR)
Ref ACC-11830/16B3Model Accu-PlusRef SK-11830/16B3Model SKYMEDRef SK-11830-16B3Ref SK-11830-16B4
Identity
- Trade Name
- ECG ROLL 118MM X 30M EUDAMEDECG Roll (118mm x 30m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-11830/16B3 EUDAMEDSKYMED EUDAMEDSK-11830/16B3 EUDAMEDSK-11830-16B3 EUDAMEDSK-11830-16B4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813064 EUDAMED09551019811466 EUDAMED09551019817604 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019813064 EUDAMED09551019811466 EUDAMED09551019817604 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 118mm X 30m 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 (4)
- EUDAMED adf6ffc5-daa8-42a3-b728-4b6bd78f40db 61 fields · synced Jul 19, 2026
- EUDAMED d690a198-a0a2-40d8-b3d2-29a215a7bb5c 61 fields · synced May 19, 2026
- EUDAMED 6dfca86c-b26b-43a8-a966-eb46a6fc3927 61 fields · synced Jun 19, 2026
- EUDAMED 734ca993-7651-477a-bed0-cc1686042737 61 fields · synced Jul 19, 2026