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Innomed 80g
EUDAMEDClass I (EU MDR)
Ref SK-8025/13R4Model SKYMEDRef SK-8025-13R4
Identity
- Trade Name
- INNOMED 80G EUDAMEDINNOMED ECG ROLL (80MM X 25M) 80G EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-8025/13R4 EUDAMEDSK-8025-13R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270638 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551026270638 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 80g 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 |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED c15e12e5-a4b8-46d5-8ef1-a62fc46b20d0 61 fields · synced Jun 18, 2026
- EUDAMED 676e8456-5edd-4c3d-9f2b-a0e297fca1e5 61 fields · synced Jun 18, 2026