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MEDIANA YM812i
EUDAMEDClass I (EU MDR)
Ref SK-MD-215280-200RSModel SKYMEDRef ACC-MD215280/200RSModel Accu-PlusRef SK-MD215280-200RS
Identity
- Trade Name
- MEDIANA YM812i EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-MD-215280-200RS EUDAMEDAccu-Plus EUDAMEDACC-MD215280/200RS EUDAMEDSK-MD215280-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270898 EUDAMED09551019814719 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026270898 EUDAMED09551019814719 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
MEDIANA YM812i 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 (3)
- EUDAMED f64322f0-9959-4319-bf69-e21e540438d3 61 fields · synced Jul 16, 2026
- EUDAMED f793a0e9-30a5-4f76-860a-ab4f2c3a6f39 61 fields · synced May 19, 2026
- EUDAMED c47132fc-5943-4cb9-adf4-d2d16009e659 61 fields · synced Jul 16, 2026