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Ecg Roll 60mm X 15m (blue Sensor
EUDAMEDClass I (EU MDR)
Ref ACC-6015/16BS3Model Accu-PlusRef SK-6015/16RBS3Model SKYMEDRef SK-6015-16BS3
Identity
- Trade Name
- ECG ROLL 60MM X 15M (BLUE SENSOR EUDAMEDECG Roll (60mm x 15m) Blue Sensor EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-6015/16BS3 EUDAMEDSKYMED EUDAMEDSK-6015/16RBS3 EUDAMEDSK-6015-16BS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812890 EUDAMED09551019811305 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019812890 EUDAMED09551019811305 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 60mm X 15m (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-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 (3)
- EUDAMED 9eb537b7-6abb-490b-b86b-829ced0560bb 61 fields · synced Oct 6, 2026
- EUDAMED a921f7cc-e1da-4da3-8afb-4f645c03e19c 61 fields · synced May 17, 2026
- EUDAMED b4ad37b6-f8b2-491f-955a-f14697fffa26 61 fields · synced Jul 25, 2026