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Mortara 9100-029-50
EUDAMEDClass I (EU MDR)
Ref SK-MO-21021-16R3Model SKYMEDRef ACC-MO21021/16R3Model Accu-PlusRef SK-MO21021-16R3
Identity
- Trade Name
- MORTARA 9100-029-50 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-MO-21021-16R3 EUDAMEDAccu-Plus EUDAMEDACC-MO21021/16R3 EUDAMEDSK-MO21021-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270966 EUDAMED09551019814801 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026270966 EUDAMED09551019814801 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 9100-029-50 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 (3)
- EUDAMED ba158de5-59ef-4e19-a21b-0c3d9e213f6b 61 fields · synced Jul 26, 2026
- EUDAMED d62c44ec-c198-43d1-977f-5882bdea9a84 61 fields · synced May 19, 2026
- EUDAMED 85f09cb8-d831-4b93-b037-8ee2a53cfe3f 61 fields · synced Jul 14, 2026