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ECG Roll (183mm x 30m)
EUDAMEDClass I (EU MDR)
Ref SK-18330/16RModel SKYMEDRef SK-18330/16R4Ref ACC-18330/16R3Model Accu-PlusRef SK-18330/16R3Ref SK-18330-16R4Ref SK-18330-16R3
Identity
- Trade Name
- ECG Roll (183mm x 30m) EUDAMEDECG ROLL 183MM X 30M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-18330/16R EUDAMEDSK-18330/16R4 EUDAMEDAccu-Plus EUDAMEDACC-18330/16R3 EUDAMEDSK-18330/16R3 EUDAMEDSK-18330-16R4 EUDAMEDSK-18330-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815839 EUDAMED09551019811510 EUDAMED09551019813101 EUDAMED09551019811503 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019815839 EUDAMED09551019811510 EUDAMED09551019813101 EUDAMED09551019811503 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 (183mm 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 (6)
- EUDAMED ee30e304-ce68-4f91-9c89-0556e2f8389f 61 fields · synced Sep 18, 2026
- EUDAMED c12c503d-b465-4d29-91e0-0fd9335605e1 61 fields · synced May 16, 2026
- EUDAMED 52cb6c16-63d6-43b3-9f2a-343cfdc0f047 61 fields · synced May 17, 2026
- EUDAMED ebe900ee-063c-4057-b0ff-a57f7fe3815d 61 fields · synced May 18, 2026
- EUDAMED cd1dc52e-e4ea-4034-9b04-eab51441bc18 61 fields · synced Jul 19, 2026
- EUDAMED dd5c9007-112d-451b-abcc-ad36bc3cccd8 61 fields · synced Sep 18, 2026