This page includes the latest FDA filings for Oftal One Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Oftal One Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3004471819 | ||||||||
| FEI Number | 3004471819 | ||||||||
| Name | Elena Morozova | ||||||||
| Owner & Operator | Oftal-One Inc | ||||||||
| Contact Address | 250 Catalonia Ave. Suite 606 Miami FL 33134 US | ||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||
| Initial Importer | N | ||||||||
| Registration Expiration | 2020-04-25 | ||||||||
| Registration Address | 250 Catalonia Ave Suite 606 Coral Gables, FL 33134 US | ||||||||
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3016248648 |
| FEI Number | 3016248648 |
| Name | OFTAL-ONE INC |
| Owner & Operator | Oftal-One Inc |
| Contact Address | 250 Catalonia Ave Suite 606 Coral Gables FL 33134 US |
| Official Correspondent |
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| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 250 Catalonia Ave Suite 606 Coral Gables, FL 33134 US |
Device Company | Device | Date |
|---|---|---|
| OFTAL-ONE INC. | OftalOnePack, Oftal-One | 2026-03-06 |
| OFTAL-ONE INC. | OftalOnePack, Oftal-One | 2026-03-06 |
| OFTAL-ONE INC. | OftalOnePack, Oftal-One | 2026-03-06 |
| OFTAL-ONE INC. | OftalOnePack | 2026-01-13 |
| OFTAL-ONE INC. | Oftal-One Pack | 2025-06-17 |
| OFTAL-ONE INC. | OftalOnePack, Oftal-One | 2025-05-26 |
Elena Morozova [Oftal-One Inc] | Kerasave | 2019-05-31 |
Elena Morozova [Oftal-One Inc] | EUSOL-C | 2016-12-20 |