Microscope RX1
Microscope RX1 (U1OM200C) is a Class I device made by Ecleris, listed in FDA GUDID since 10 Aug 2022 (UDI-DI B366U1OM200CRX1), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB366U1OM200CRX1 | Date10 Aug 2022 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Microscope
- Generic name
- General-purpose surgical microscope
- Model / Ref / Catalog
- RX1, U1OM200C
- Primary DI / UDI-DI
- B366U1OM200CRX1
- FDA product code
- EPT
- GMDN term
- General-purpose surgical microscope
- Device class
- Class I
- Regulation number
- 878.4700
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose surgical microscope.