Microclear FC-03
by Suzhou Microclear Medical Instruments Co., Ltd.
Microclear FC-03 is a Class II device made by Suzhou Microclear Medical Instruments Co., Ltd., registered in EUDAMED and listed in FDA GUDID since 27 Jan 2021 (UDI-DI 06970990160067), active as of 22 Oct 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06970990160067 | Date27 Jan 2021 | StatusListed |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 06970990160067
Across registries
- EUDAMED Active
- FDA GUDID UDI-DI 06970990160067 listed 27 Jan 2021 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Microclear
- Generic name
- Ophthalmic fundus camera
- Model / reference
- FC-03
- Primary DI / UDI-DI
- 06970990160067
- FDA product code
- PJZ
- GMDN term
- Ophthalmic fundus camera
- Device class
- Class II
- Regulation number
- 886.1120
- GUDID distribution status
- In Commercial Distribution
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