Identity
- Device Name
- AiTiAMI EUDAMED
- Model / Reference
- AiTiAMI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809826560413 EUDAMED
- Basic UDI-DI
- 880982656AiTiAMILW EUDAMED
- Direct Marketing DI
- 08809826560413 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
AiTiAMI by Medical AI Co., Ltd. — Class IIa — 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 | 880982656AiTiAMILW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medical AI Co., Ltd.
- EUDAMED SRN
- KR-MF-000045682
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 8f686efd-337b-441d-ab4c-439466db397c 61 fields · synced Sep 17, 2026
- EUDAMED 00c7fe5c-28d0-429f-b992-36332bf67d05 61 fields · synced Sep 17, 2026