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Innomed 80g
EUDAMEDClass I (EU MDR)
Ref SK-8025/13R3Model SKYMEDRef ACC-8025/13R3Model Accu-Plus
Identity
- Trade Name
- INNOMED 80G EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-8025/13R3 EUDAMEDAccu-Plus EUDAMEDACC-8025/13R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271659 EUDAMED09551019814467 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026271659 EUDAMED09551019814467 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 c99fdafe-4cfd-4598-9003-1e41c82036db 61 fields · synced Oct 6, 2026
- EUDAMED a1e77943-8680-4db8-9d9c-f42eaa54e32e 61 fields · synced May 18, 2026