← Back to catalogue
Ecg Roll 210mm X 25m
EUDAMEDClass I (EU MDR)
Ref ACC-21025/16R4Model Accu-PlusRef SK-21025/16R3Model SKYMEDRef SK-21025-16R3Ref APP-21025-16R4Model ALPHA-PLUSRef APP-21025-16R3
Identity
- Trade Name
- ECG ROLL 210MM X 25M EUDAMEDECG ROLL (210mm X 25m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-21025/16R4 EUDAMEDSKYMED EUDAMEDSK-21025/16R3 EUDAMEDSK-21025-16R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-21025-16R4 EUDAMEDAPP-21025-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813132 EUDAMED09551019811527 EUDAMED09551026273318 EUDAMED09551026273301 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019813132 EUDAMED09551019811527 EUDAMED09551026273318 EUDAMED09551026273301 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 210mm 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-APNG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED 9314e210-1062-4b6b-9a5d-3824c196b5c7 61 fields · synced Jul 23, 2026
- EUDAMED bff28d42-b9d8-4e89-a7c0-a2f63756fb23 61 fields · synced May 16, 2026
- EUDAMED d14f7fd5-e470-47fb-b5f4-339c5d67865e 61 fields · synced Jun 19, 2026
- EUDAMED eced14fb-3c13-4ad2-884e-cff1b4a585e5 61 fields · synced Jul 13, 2026
- EUDAMED 408c8ded-97e0-42e6-b75e-6de32e7d9374 61 fields · synced Jul 23, 2026