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Ecg Roll 106mm X 20m
EUDAMEDClass I (EU MDR)
Ref ACC-10620/16R3Model Accu-PlusRef ACC-10620/16R4Ref SK-10620/16RModel SKYMEDRef SK-10620/16R4Ref SK-10620-16R4Ref APP-10620-16R3Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL 106MM X 20M EUDAMEDECG Roll (106mm x 20m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-10620/16R3 EUDAMEDACC-10620/16R4 EUDAMEDSKYMED EUDAMEDSK-10620/16R EUDAMEDSK-10620/16R4 EUDAMEDSK-10620-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-10620-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812982 EUDAMED09551019812999 EUDAMED09551019815808 EUDAMED09551019811404 EUDAMED09551026273066 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019812982 EUDAMED09551019812999 EUDAMED09551019815808 EUDAMED09551019811404 EUDAMED09551026273066 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 106mm X 20m 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 (6)
- EUDAMED 49f2ca0b-019f-4438-b5dd-0daedf8e5e72 61 fields · synced Oct 6, 2026
- EUDAMED 5cdac1df-2dfa-448d-9d42-ea45e839bf6c 61 fields · synced May 17, 2026
- EUDAMED a6bf8b0d-202e-4d93-a057-8e63ea86cd5e 61 fields · synced May 17, 2026
- EUDAMED b3fcbd71-943d-4af2-b1b6-1f7c08c0e846 61 fields · synced May 18, 2026
- EUDAMED 6bb93f37-66fa-40c6-8b8d-b08535f056c1 61 fields · synced Jul 9, 2026
- EUDAMED 2ccac76f-def0-4488-a4e4-c6ee05f0afdc 61 fields · synced Aug 2, 2026