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ECG Roll (50mm x 30m) Blue Sensor
EUDAMEDClass I (EU MDR)
Ref SK-5030/16BS3Model SKYMEDRef ACC-5030/16BS3Model Accu-PlusRef SK-5030-16BS3Ref APP-5030-16BS3Model ALPHA-PLUS
Identity
- Trade Name
- ECG Roll (50mm x 30m) Blue Sensor EUDAMEDECG ROLL 50MM X 30M (BLUE SENSOR) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5030/16BS3 EUDAMEDAccu-Plus EUDAMEDACC-5030/16BS3 EUDAMEDSK-5030-16BS3 EUDAMEDALPHA-PLUS EUDAMEDAPP-5030-16BS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811213 EUDAMED09551019812807 EUDAMED09551026272618 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811213 EUDAMED09551019812807 EUDAMED09551026272618 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 (50mm x 30m) Blue Sensor 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 (4)
- EUDAMED e788d68f-6ba9-4199-bcae-f31ba2ac97a9 61 fields · synced Sep 17, 2026
- EUDAMED df453d60-8583-4227-b517-6e5099674673 61 fields · synced May 17, 2026
- EUDAMED 3db05455-8c4a-4cc4-b51d-ed9505b391af 61 fields · synced Jun 20, 2026
- EUDAMED e5996397-8638-45bf-8b73-73ef9e29cd3c 61 fields · synced Jul 18, 2026