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Hdi-P
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R-USM-714Model HDI-U15DF Model HDI-U10DF
Identity
- Trade Name
- HDI-P EUDAMEDFDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Medical Image Processing Unit (Intra Oral Imaging System) EUDAMEDDigital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy. FDA UDI
- Model / Reference
- HDI-U15DF EUDAMEDFDA UDIR-USM-714 EUDAMEDHDI-U10DF EUDAMEDFDA UDI
- Description
- Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018600443 EUDAMEDFDA UDI08800018600436 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800018600443 EUDAMEDB-08800018600436 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
Hdi-P 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-08800018600443 | 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 cb9cca06-f47b-40e6-9c56-2f25d8c3acb7 61 fields · synced Jul 28, 2026
- FDA UDI 60f30939-9985-4e86-abce-b25d04fcb71f 34 fields · synced May 30, 2026
- FDA UDI 4a90a7b5-883d-433d-9667-f10d699a36fa 34 fields · synced May 30, 2026
- EUDAMED bc148ab4-5735-4486-b837-51e8457a4d2e 61 fields · synced Jul 28, 2026