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Sign in to claim this brandDiopsys, Inc.
United States·US-MF-000038933
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1000, Kreider Drive, Middletown, United States
- Website
- www.opzira.com
- —
- —
- [email protected]
- Phone
- +442039962120
- PRRC Contact
- Debra Macrae
- EUDAMED SRN
- US-MF-000038933
- FDA FEI Number
- 3004174467
- DUNS Number
- 009972345
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Diopsys® | 2320-0020-00 | FDA UDI | Class II | Active |
| Diopsys® | NOVA 2.19 | FDA UDI | Class II | Active |
| Diopsys® | 2400-0025-00 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0001-02 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0002-02 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0001-00 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0002-01 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0001-01 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0002-00 | FDA UDI | Class II | Active |
| Diopsys® | 4028-0010-00 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0010-00 | FDA UDI | Class II | Active |
| Diopsys® | 6020-0011-00 | FDA UDI | Class II | Active |
| Enfanttm | K043491 | FDA 510(k) | Class II | Active |
| Diopsys Nova Vep Vision Testing System | K101763 | FDA 510(k) | Class II | Active |
| NOVA Vision Testing System | 4028-0005-00 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
- Obelis s.a. BE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 2, 2007 | Z-1437-2010 | — | terminated | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007. |
| Sep 15, 2004 | Z-0186-05 | — | terminated | The firm established no medical device quality system, no established quality plan and no established quality procedures. |