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Ecg Roll 75mm X 25m
EUDAMEDClass I (EU MDR)
Ref ACC-7525/16R4Model Accu-PlusRef APP-7525-16R4Model ALPHA-PLUSRef ACC-7525/16R3Ref SK-7525-13R3Model SKYMEDRef APP-7525-13R4Ref SK-7525-16R3Ref APP-7525-13R3
Identity
- Trade Name
- ECG ROLL 75MM X 25M EUDAMEDECG ROLL (75MM X 25M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-7525/16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-7525-16R4 EUDAMEDACC-7525/16R3 EUDAMEDSKYMED EUDAMEDSK-7525-13R3 EUDAMEDAPP-7525-13R4 EUDAMEDSK-7525-16R3 EUDAMEDAPP-7525-13R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812920 EUDAMED09551026272922 EUDAMED09551019818434 EUDAMED09551019817970 EUDAMED09551026272908 EUDAMED09551019817994 EUDAMED09551026272892 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019812920 EUDAMED09551026272922 EUDAMED09551019818434 EUDAMED09551019817970 EUDAMED09551026272908 EUDAMED09551019817994 EUDAMED09551026272892 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 75mm 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 |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (7)
- EUDAMED 08e9e012-3677-4a25-a3e3-e58c92eabd05 61 fields · synced Jul 31, 2026
- EUDAMED eb5d5378-a235-4042-980f-49b177eb673e 61 fields · synced Jun 20, 2026
- EUDAMED b3025a3a-d79c-4d06-a6fa-7f2d9f55356c 61 fields · synced Jun 20, 2026
- EUDAMED cc27c419-c231-4cc3-9dcc-9178096a79af 61 fields · synced Jul 9, 2026
- EUDAMED 0f32eb15-27c7-4766-a162-35d824848130 61 fields · synced Jul 17, 2026
- EUDAMED 147a99e6-dcd9-4dbd-a4ba-a87c0f1d0390 61 fields · synced Jul 29, 2026
- EUDAMED 6e5dcdad-6a97-4c5f-9697-9b68d4c3d003 61 fields · synced Jul 31, 2026