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ECG ROLL (50mm X 40m)
EUDAMEDClass I (EU MDR)
Ref SK-5040/16R4Model SKYMEDRef SK-5040-16R4
Identity
- Trade Name
- ECG ROLL (50mm X 40m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5040/16R4 EUDAMEDSK-5040-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811237 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019811237 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 40m) 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 (2)
- EUDAMED 9bb90738-0179-4a21-863f-d8d5f0f53545 61 fields · synced Jun 19, 2026
- EUDAMED 2e7df90b-78d2-48a5-af2a-89aa8809a0dd 61 fields · synced Jun 19, 2026