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ECG ROLL (145mm X 30m)
EUDAMEDClass I (EU MDR)
Ref SK-14530/16R3Model SKYMEDRef ACC-14530/16R4Model Accu-PlusRef SK-14530-16R3Ref APP-14530-16R3Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL (145mm X 30m) EUDAMEDECG ROLL 145MM X 30M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-14530/16R3 EUDAMEDAccu-Plus EUDAMEDACC-14530/16R4 EUDAMEDSK-14530-16R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-14530-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811480 EUDAMED09551019813095 EUDAMED09551026273240 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811480 EUDAMED09551019813095 EUDAMED09551026273240 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 (145mm 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-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 4a108a29-c840-44eb-a628-61c6aee9d084 61 fields · synced Aug 2, 2026
- EUDAMED 7c5e5e23-3d16-4f15-9696-8dbc47318938 61 fields · synced May 18, 2026
- EUDAMED 4e3748d6-ea7e-437a-a7da-2b092016c035 61 fields · synced Jun 18, 2026
- EUDAMED 52102b8c-7b43-4c75-ad10-77124a87bea0 61 fields · synced Jul 12, 2026