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MEDIGATE MECA812i
EUDAMEDClass I (EU MDR)
Ref SK-ME-215280-200RSModel SKYMEDRef ACC-ME215280/200RSModel Accu-PlusRef APP-ME215280-200RSModel ALPHA-PLUSRef SK-ME215280-200RS
Identity
- Trade Name
- MEDIGATE MECA812i EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-ME-215280-200RS EUDAMEDAccu-Plus EUDAMEDACC-ME215280/200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-ME215280-200RS EUDAMEDSK-ME215280-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270904 EUDAMED09551019814726 EUDAMED09551026271857 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551026270904 EUDAMED09551019814726 EUDAMED09551026271857 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
MEDIGATE MECA812i 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 (4)
- EUDAMED 1ae44032-7944-4802-b9fa-3df7b726bf88 61 fields · synced Jul 27, 2026
- EUDAMED 5407b138-5b9a-4be5-9ae4-9d5f65c427f7 61 fields · synced May 17, 2026
- EUDAMED ebc6c597-08a7-4ecb-88d8-0ef3f44980fc 61 fields · synced Jul 11, 2026
- EUDAMED e6b36634-945e-4120-8c74-707a0ea29450 61 fields · synced Jul 27, 2026