← Back to catalogue
ECG ROLL (60mm X 30m)
EUDAMEDClass I (EU MDR)
Ref SK-6030/16R4Model SKYMEDRef ACC-6030/16R3Model Accu-PlusRef ACC-6030/16R4Ref APP-6030-16R3Model ALPHA-PLUSRef APP-6030-16R4Ref SK-6030-16R4
Identity
- Trade Name
- ECG ROLL (60mm X 30m) EUDAMEDECG ROLL 60MM X 30M EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-6030/16R4 EUDAMEDAccu-Plus EUDAMEDACC-6030/16R3 EUDAMEDACC-6030/16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-6030-16R3 EUDAMEDAPP-6030-16R4 EUDAMEDSK-6030-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811329 EUDAMED09551019812906 EUDAMED09551019812913 EUDAMED09551026272816 EUDAMED09551026272823 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811329 EUDAMED09551019812906 EUDAMED09551019812913 EUDAMED09551026272816 EUDAMED09551026272823 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 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 (6)
- EUDAMED dbbfaec8-df6d-4568-bbf2-15b5572d34cf 61 fields · synced Aug 4, 2026
- EUDAMED caabacc2-f76e-40ae-8ef7-371e86cc01e8 61 fields · synced May 17, 2026
- EUDAMED 14f525cd-c250-4130-850b-3c608316fe90 61 fields · synced May 17, 2026
- EUDAMED c2db7c04-e8f3-44f2-8638-1882ce1da786 61 fields · synced Jul 9, 2026
- EUDAMED 2039647c-7e4a-45b9-acc2-d84f8c97764d 61 fields · synced Aug 2, 2026
- EUDAMED c1be4dad-a474-427d-815f-d754abec66e8 61 fields · synced Aug 4, 2026