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Mortara 9100-028-50
EUDAMEDClass I (EU MDR)
Ref SK-MO-108140-200RSModel SKYMEDRef ACC-MO108140/200RSModel Accu-PlusRef APP-MO108140-200RSModel ALPHA-PLUSRef SK-MO108140-200RS
Identity
- Trade Name
- MORTARA 9100-028-50 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-MO-108140-200RS EUDAMEDAccu-Plus EUDAMEDACC-MO108140/200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-MO108140-200RS EUDAMEDSK-MO108140-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270959 EUDAMED09551019814795 EUDAMED09551026271918 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551026270959 EUDAMED09551019814795 EUDAMED09551026271918 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
Mortara 9100-028-50 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 e05c31d5-32c4-410d-a5f4-1cb9b58d88ee 61 fields · synced Jul 17, 2026
- EUDAMED b9e546d3-9e1a-49da-8eba-74aac9bb6148 61 fields · synced May 19, 2026
- EUDAMED 735ecbdd-f2ad-4b21-85bb-4b27a5620039 61 fields · synced Jul 14, 2026
- EUDAMED 1ca8df73-fd33-46bc-a47a-338f239ae4b7 61 fields · synced Jul 17, 2026