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Mortara 9100-001
EUDAMEDClass I (EU MDR)
Ref SK-MO-5070-200RSModel SKYMEDRef ACC-MO5070/200RSModel Accu-PlusRef SK-MO5070-200RSRef APP-MO5070-200RSModel ALPHA-PLUS
Identity
- Trade Name
- MORTARA 9100-001 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-MO-5070-200RS EUDAMEDAccu-Plus EUDAMEDACC-MO5070/200RS EUDAMEDSK-MO5070-200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-MO5070-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270935 EUDAMED09551019814771 EUDAMED09551026271994 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551026270935 EUDAMED09551019814771 EUDAMED09551026271994 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 9100-001 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 f600c983-1f5a-480b-899c-d6d55fae765f 61 fields · synced Jul 27, 2026
- EUDAMED 8a389eee-9fc7-4a31-be70-1ac78f3abf2e 61 fields · synced May 19, 2026
- EUDAMED d9fb66b8-a6c3-46da-b33a-668ab76ef807 61 fields · synced Jul 9, 2026
- EUDAMED 5cbaedbc-9af5-473c-9487-bfeabcc53e3b 61 fields · synced Jul 27, 2026