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Mortara 9100-026-11
EUDAMEDClass I (EU MDR)
Ref ACC-MO215280/250RS4Model Accu-PlusRef SK-MO-215280-250RS4Model SKYMEDRef SK-MO215280-250RS4
Identity
- Trade Name
- MORTARA 9100-026-11 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-MO215280/250RS4 EUDAMEDSKYMED EUDAMEDSK-MO-215280-250RS4 EUDAMEDSK-MO215280-250RS4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814849 EUDAMED09551026271024 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551019814849 EUDAMED09551026271024 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 9100-026-11 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 | 955101981MCRP-APNG | 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 ee4f3cac-1351-425a-b48f-b1bb241f24d5 61 fields · synced Jul 14, 2026
- EUDAMED 8aeee048-7f87-40a2-a318-685788fa4bcb 61 fields · synced May 18, 2026
- EUDAMED 0b642cf7-668d-417a-8a20-5754e7f76d82 61 fields · synced Jul 14, 2026