Demetra Analytics Toolkit
by Barco NV
Demetra Analytics Toolkit (K9302003B) is a Class II device made by Barco NV, listed in FDA GUDID since 28 Jun 2021 (UDI-DI 05415334036192), not in commercial distribution (GUDID) as of 9 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05415334036192 | Date28 Jun 2021 | StatusListed |
Official records
- AccessGUDID record 05415334036192
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Demetra
- Generic name
- Dermatoscope, digital
- Model / Ref / Catalog
- Analytics Toolkit, K9302003B
- Primary DI / UDI-DI
- 05415334036192
- FDA product code
- PSN
- GMDN term
- Dermatoscope, digital
- Device class
- Class II
- Regulation number
- 878.4580
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code PSN (Light based imaging).
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- VivaScope System 1500, 3000, or both by Caliber Imaging & Diagnostics, Inc.
- Demetra BDEM-01 Dermatoscope by Barco N.V.
- VivaScope System by Caliber Imaging & Diagnostics, Inc.
- VIVASCOPE SYSTEM, MODEL 1500, 3000 by Lucid, Inc.
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