Mp-1S
Mp-1S is a Class II device made by Nidek Technologies SRL, listed in FDA GUDID since 4 Aug 2016 (UDI-DI B310MP1S0), registry data as of 8 Jun 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB310MP1S0 | Date4 Aug 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Ophthalmic fundus camera
- Model / reference
- MP-1S
- Description
- The MP-1S MICRO PERIMETER is indicated for use as: ·Color retinography ·Fixation examiner ·Fundus-related microperimetry ·Visual rehabilitation
- Primary DI / UDI-DI
- B310MP1S0
- FDA product code
- HKI, HPT
- GMDN term
- Ophthalmic fundus camera
- Device class
- Class II
- Regulation number
- 886.1120, 886.1605
- GUDID distribution status
- In Commercial Distribution
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