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Ecg Roll 112mm X 30m
EUDAMEDClass I (EU MDR)
Ref ACC-11230/16R4Model Accu-PlusRef ACC-11230/16R3Ref SK-11230/16R4Model SKYMEDRef SK-11230-16R4Ref APP-11230-16R4Model ALPHA-PLUSRef APP-11230-16R3
Identity
- Trade Name
- ECG ROLL 112MM X 30M EUDAMEDECG ROLL (112mm X 30m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-11230/16R4 EUDAMEDACC-11230/16R3 EUDAMEDSKYMED EUDAMEDSK-11230/16R4 EUDAMEDSK-11230-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-11230-16R4 EUDAMEDAPP-11230-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813057 EUDAMED09551019813040 EUDAMED09551019811459 EUDAMED09551026273196 EUDAMED09551026273189 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019813057 EUDAMED09551019813040 EUDAMED09551019811459 EUDAMED09551026273196 EUDAMED09551026273189 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 112mm 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-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 1c2cb6f3-fe00-4e45-b1ef-7e03d3de4ec3 61 fields · synced Jul 30, 2026
- EUDAMED b255ef5e-0dc7-4e6d-853c-fb98c32b7f2d 61 fields · synced May 17, 2026
- EUDAMED 54cfb43e-911c-41d5-bdb7-720a7b7a5185 61 fields · synced May 18, 2026
- EUDAMED ffc4ef85-bcaa-4609-82ed-b9c383893df4 61 fields · synced Jul 9, 2026
- EUDAMED f4b941bf-66fb-45cf-932c-c6246fb85926 61 fields · synced Jul 10, 2026
- EUDAMED 3a4e5d03-e6c7-4bda-af16-adc1102aa3ed 61 fields · synced Jul 12, 2026