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Ecg Roll 215mm X 30m
EUDAMEDClass I (EU MDR)
Ref ACC-21530/16R3Model Accu-PlusRef SK-21530/16R4Model SKYMEDRef SK-21530-16R4
Identity
- Trade Name
- ECG ROLL 215MM X 30M EUDAMEDECG ROLL (215mm X 30m) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-21530/16R3 EUDAMEDSKYMED EUDAMEDSK-21530/16R4 EUDAMEDSK-21530-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813163 EUDAMED09551019811572 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019813163 EUDAMED09551019811572 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 215mm 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-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 84be4759-fb26-493f-b0c1-e7172d67631f 61 fields · synced Jul 16, 2026
- EUDAMED d9ed962a-1aa4-4f07-8790-8500a88afff9 61 fields · synced May 18, 2026
- EUDAMED 8bfd3765-f8fb-49c8-863c-9b31dcf99b37 61 fields · synced Jul 16, 2026