Identity
- Trade Name
- VATECH EzCam EUDAMEDEzCam FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- Intraoral Camera EUDAMEDFDA UDI
- Model / Reference
- EzCam-V1.0 EUDAMEDEzCam-Regular kit FDA UDI
- Description
- Intraoral Camera FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800096901302 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000969IOC01LG EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z12119080 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Intraoral camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VATECH EzCam by Dentall co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000969IOC01LG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DENTALL Co., Ltd.
- EUDAMED SRN
- KR-MF-000013640
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cb7853ab-3d24-448c-a184-4caceb256a5d 61 fields · synced Jun 18, 2026
- FDA UDI 4c97dac8-350d-4a8e-be52-b1f9f4251619 34 fields · synced May 30, 2026