Identity
- Trade Name
- MEDISTEP M Pro EUDAMED
- Device Name
- MEDISTEP M Pro EUDAMED
- Model / Reference
- MEDISTEP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800337580013 EUDAMED
- Basic UDI-DI
- 880033758MEDISTEPMProJG EUDAMED
- EMDN Code
- Z12062592 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MEDISTEP M Pro by Aitstudio CO., Ltd. — 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 | 880033758MEDISTEPMProJG | Class I | Active |
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Manufacturer
- Manufacturer
- Aitstudio CO., Ltd.
- EUDAMED SRN
- KR-MF-000051332
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 53f42cc5-fca3-4c4c-9ee9-e045dca369fc 61 fields · synced Jun 18, 2026