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Diagnocat AI
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref Diagnocat AI v. 3.2510(k) K252934
by Dgnct Llc
Identity
- Trade Name
- Diagnocat AI EUDAMED
- Device Name
- Diagnocat AI EUDAMED
- Model / Reference
- Diagnocat AI v. 3.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860010268001 EUDAMED
- Basic UDI-DI
- 08600102680DiagnocatAI35X EUDAMED
- Direct Marketing DI
- 00860010268001 EUDAMED
- EMDN Code
- Z12119092 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Czechia 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
Diagnocat AI by Dgnct Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252934 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08600102680DiagnocatAI35X | Class I | Active |
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Manufacturer
- Manufacturer
- Dgnct Llc
- EUDAMED SRN
- US-MF-000035521
- FDA Applicant
- DGNCT, LLC
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (2)
- EUDAMED c6763a4c-7da6-498b-8b32-d0e60d96b43c 85 fields · synced Jun 18, 2026
- FDA 510(k) K252934 1 fields · synced May 18, 2026