Identity
- Trade Name
- FixR EUDAMED
- Device Name
- Software EUDAMED
- Model / Reference
- FIXR-1080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809921440016 EUDAMED
- Basic UDI-DI
- 880992144FR108FE EUDAMED
- EMDN Code
- Z12110192 INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I 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
Category: Dental x-ray image interpretive software
FixR by Yoat Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray image interpretive software.
- Videa Perio Assist — Videahealth, Inc. · Class II
- Overjet Periapical Radiolucency Assist — OVERJET · Class II
- Planungshilfe Zahnersatz (PZE) — Dampsoft GmbH · Class IIa
- Overjet Image Enhancement Assist — OVERJET · Class II
- Overjet Dental Assist — OVERJET · Class II
- SMART Guide Szoftverrendszer 3.0 — Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság · Class IIb
- Videa Dental Assist — Videahealth, Inc. · Class II
- Overjet Calculus Assist — OVERJET · Class II
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 | 880992144FR108FE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yoat Co., Ltd.
- EUDAMED SRN
- KR-MF-000035220
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ad16b4b0-a5e3-4b5f-bd86-cd23e072e0d2 61 fields · synced Jun 18, 2026