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ECG ROLL (80mm X 25m)
EUDAMEDClass I (EU MDR)
Ref SK-8025/13R4Model SKYMEDRef ACC-8025/13R4Model Accu-PlusRef SK-8025/13R3Ref SK-8025-13R4Ref ACC-8025/16R4Ref SK-8025-16R4Ref SK-8025-13R3Ref ACC-8025/16R3Ref APP-8025-16R3Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL (80mm X 25m) EUDAMEDECG ROLL 80MM X 25M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-8025/13R4 EUDAMEDAccu-Plus EUDAMEDACC-8025/13R4 EUDAMEDSK-8025/13R3 EUDAMEDSK-8025-13R4 EUDAMEDACC-8025/16R4 EUDAMEDSK-8025-16R4 EUDAMEDSK-8025-13R3 EUDAMEDACC-8025/16R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-8025-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811350 EUDAMED09551019812944 EUDAMED09551019810414 EUDAMED09551019818458 EUDAMED09551019818014 EUDAMED09551019818441 EUDAMED09551026272991 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811350 EUDAMED09551019812944 EUDAMED09551019810414 EUDAMED09551019818458 EUDAMED09551019818014 EUDAMED09551019818441 EUDAMED09551026272991 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 (80mm 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 (9)
- EUDAMED 65bb8952-3d35-44ee-ad15-35dcb0fc50e9 61 fields · synced Sep 17, 2026
- EUDAMED 7e4e384d-1bac-491c-b456-a04d4ee53347 61 fields · synced May 17, 2026
- EUDAMED 72c7ce4d-bc4d-49c5-a0d6-bc86defbea55 61 fields · synced May 19, 2026
- EUDAMED 986037ee-18de-438f-9014-3f40801e89bd 61 fields · synced Jun 19, 2026
- EUDAMED ad9471a6-cceb-4c71-8949-4df79a838a9a 61 fields · synced Jul 11, 2026
- EUDAMED cb8f105e-42c4-421c-8453-e5e69373742e 61 fields · synced Jul 17, 2026
- EUDAMED a3d7c91f-eac8-4ca5-a149-b7a1c2b825a5 61 fields · synced Jul 19, 2026
- EUDAMED 4ab838b5-a1b7-4893-a310-bd383fb5172b 61 fields · synced Jul 28, 2026
- EUDAMED 06c862d3-b682-443d-829f-5b9983804461 61 fields · synced Sep 17, 2026