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ECG Roll (110mm x 25m)
EUDAMEDClass I (EU MDR)
Ref SK-11025/16R3Model SKYMEDRef ACC-11025/16R4Model Accu-PlusRef ACC-11025/13R3Ref APP-11025-16R3Model ALPHA-PLUSRef APP-11025-16R4Ref SK-11025-16R3Ref APP-11025-13R4Ref APP-11025-13R3Ref SK-11025-13R3
Identity
- Trade Name
- ECG Roll (110mm x 25m) EUDAMEDECG ROLL 110MM X 25M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-11025/16R3 EUDAMEDAccu-Plus EUDAMEDACC-11025/16R4 EUDAMEDACC-11025/13R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-11025-16R3 EUDAMEDAPP-11025-16R4 EUDAMEDSK-11025-16R3 EUDAMEDAPP-11025-13R4 EUDAMEDAPP-11025-13R3 EUDAMEDSK-11025-13R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810452 EUDAMED09551019813019 EUDAMED09551019818465 EUDAMED09551026273127 EUDAMED09551026273134 EUDAMED09551026273110 EUDAMED09551026273103 EUDAMED09551019818038 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019810452 EUDAMED09551019813019 EUDAMED09551019818465 EUDAMED09551026273127 EUDAMED09551026273134 EUDAMED09551026273110 EUDAMED09551026273103 EUDAMED09551019818038 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 (110mm x 25m) 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 (9)
- EUDAMED def7dc44-442a-41f5-880d-0bb39f9ac211 61 fields · synced Aug 4, 2026
- EUDAMED d59594aa-e20b-406d-a2db-de653e4bf887 61 fields · synced May 16, 2026
- EUDAMED 6e675ab8-3194-4df6-8e64-8c1e02784660 61 fields · synced Jul 9, 2026
- EUDAMED ffd70028-f121-4f44-8efc-d632f24a97c6 61 fields · synced Jul 11, 2026
- EUDAMED a27ee695-25a7-41e3-8e85-2f379311f7ca 61 fields · synced Jul 24, 2026
- EUDAMED abfc392c-2cd3-413b-a91e-7901588fcd26 61 fields · synced Jul 27, 2026
- EUDAMED 9a8a6844-4d3a-4b84-ba8a-4b93c4875517 61 fields · synced Jul 29, 2026
- EUDAMED a6fb290b-c5b1-4a7c-b2a9-b68b9957fb01 61 fields · synced Jul 31, 2026
- EUDAMED 5a748ae5-5df2-430e-9cd2-36ad35d63a41 61 fields · synced Aug 4, 2026