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ECG ROLL (45mm X 30m)
EUDAMEDClass I (EU MDR)
Ref SK-4530/16R4Model SKYMEDRef ACC-4530/16R4Model Accu-PlusRef SK-4530-16R4Ref APP-4530-16R3Model ALPHA-PLUS
Identity
- Trade Name
- ECG ROLL (45mm X 30m) EUDAMEDECG ROLL 45MM X 30M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-4530/16R4 EUDAMEDAccu-Plus EUDAMEDACC-4530/16R4 EUDAMEDSK-4530-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-4530-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811190 EUDAMED09551019812784 EUDAMED09551026272519 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811190 EUDAMED09551019812784 EUDAMED09551026272519 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 (45mm 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-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 71953b4a-9ba1-4b46-b334-918b14e441e1 61 fields · synced Jul 28, 2026
- EUDAMED 4efbf6d5-27bf-446f-b097-1fbb65931a04 61 fields · synced May 19, 2026
- EUDAMED d6f2c911-2a7e-4a66-8a9e-c57685242302 61 fields · synced Jul 13, 2026
- EUDAMED eb7e3f47-6586-4645-98cc-6cfdb408e958 61 fields · synced Jul 28, 2026