Identity
- Trade Name
- MINDSTEP EUDAMED
- Device Name
- MINDSTEP EUDAMED
- Model / Reference
- MINDSTEP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05070002758303 EUDAMED
- Basic UDI-DI
- 50700027583AA01AN EUDAMED
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Mindstep by Mindset Technologies 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 | 50700027583AA01AN | Class I | Active |
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Manufacturer
- Manufacturer
- Mindset Technologies Ltd
- EUDAMED SRN
- UK-MF-000042217
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED d97edecb-f62f-43aa-8f09-097beebc9fcd 61 fields · synced Oct 7, 2026