← Back to catalogue
ECG Roll (210mm x 30m)
EUDAMEDClass I (EU MDR)
Ref SK-21030/16R3Model SKYMEDRef SK-21030/16R4Ref ACC-21030/16R3Model Accu-PlusRef ACC-21030/16R4Ref SK-21030-16R3Ref SK-21030-16R4Ref APP-21030-16R4Model ALPHA-PLUS
Identity
- Trade Name
- ECG Roll (210mm x 30m) EUDAMEDECG Rolls (210mm x 30m) EUDAMEDECG ROLL 210MM X 30M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-21030/16R3 EUDAMEDSK-21030/16R4 EUDAMEDAccu-Plus EUDAMEDACC-21030/16R3 EUDAMEDACC-21030/16R4 EUDAMEDSK-21030-16R3 EUDAMEDSK-21030-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-21030-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810483 EUDAMED09551019810421 EUDAMED09551019810957 EUDAMED09551019811015 EUDAMED09551026273332 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019810483 EUDAMED09551019810421 EUDAMED09551019810957 EUDAMED09551019811015 EUDAMED09551026273332 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 (210mm 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (7)
- EUDAMED 623ac35d-5191-48a7-a604-85f5575d3fa4 61 fields · synced Jul 31, 2026
- EUDAMED 70579012-6577-4e95-b0a1-e6f21ef24bf6 61 fields · synced May 17, 2026
- EUDAMED 617b3f2a-2f8b-4b69-a72f-51ba3132493d 61 fields · synced May 18, 2026
- EUDAMED dda49ef7-2352-463e-a345-f7cdcda9b34e 61 fields · synced May 18, 2026
- EUDAMED 02f1b703-74ef-49ff-b099-76a446a53cc1 61 fields · synced Jul 11, 2026
- EUDAMED d494708b-6243-468b-a514-2269ac7f1b48 61 fields · synced Jul 17, 2026
- EUDAMED 58a1d7a3-bb0c-43f7-8310-903454ae5875 61 fields · synced Jul 31, 2026