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EzSensor HD
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R-USM-712Model IOS-U20VFModel IOS-U15VFModel IOS-U15IF
Identity
- Trade Name
- EzSensor HD EUDAMEDFDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Medical Image Processing Unit (Intra Oral Imaging System) EUDAMEDEzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy. EzSensor is a digital X-ray imaging system designed specifically for dental radiography within the oral cavity. The system captures X-ray images and makes them available for display and storage across your computer network. FDA UDI
- Model / Reference
- IOS-U20VF EUDAMEDR-USM-712 EUDAMEDIOS-U15VF EUDAMEDIOS-U15IF EUDAMEDFDA UDI
- Description
- EzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy. EzSensor is a digital X-ray imaging system designed specifically for dental radiography within the oral cavity. The system captures X-ray images and makes them available for display and storage across your computer network. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018600856 EUDAMED08800018600849 EUDAMED08800018600214 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800018600856 EUDAMEDB-08800018600849 EUDAMEDB-08800018600214 EUDAMED
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EzSensor HD by Rayence Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800018600856 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Rayence Co., Ltd.
- EUDAMED SRN
- KR-MF-000014713
- Authorised Representative
- VATECH GLOBAL FRANCE SARL FR-AR-000009694
Sources (4)
- EUDAMED ddb71c73-0fa9-431a-9f60-719dfa9ce5e6 61 fields · synced Aug 3, 2026
- EUDAMED 0961bc3b-6609-43d3-88b4-d26dd2c7f3b9 61 fields · synced May 17, 2026
- FDA UDI 8bda4a8a-fd3b-417f-849c-c2cfc43bf36e 34 fields · synced May 30, 2026
- EUDAMED a3368019-e818-4bc1-aac5-505be87456d7 61 fields · synced Jul 29, 2026