← Back to catalogue
Innomed Ecg Roll 58mm X 25m
EUDAMEDClass I (EU MDR)
Ref SK-5825/16R3Model SKYMEDRef SK-5825-16R3
Identity
- Trade Name
- INNOMED ECG ROLL 58MM X 25M EUDAMEDINNOMED ECG ROLL (58MM X 25M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5825/16R3 EUDAMEDSK-5825-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270591 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551026270591 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
Innomed Ecg Roll 58mm 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 | 955102627MCRP-SMMG | 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 (2)
- EUDAMED 0f81a8ae-192d-40c0-81b3-4e943abb1a35 61 fields · synced Jun 18, 2026
- EUDAMED 747a3388-b662-413d-8cfc-7f6e7d1f442d 61 fields · synced Jun 18, 2026