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Oftal-One Inc

Country not established FDA establishment FEI 3016248648

Devices
6
Registrations
FDA
FDA recalls
0

What Oftal-One Inc makes

Oftal-One Inc manufactures general surgical procedure kits and ophthalmic surgical procedure kits, both non-medicated and single-use. These include products such as OftalOnePack and Oftal-One Pack.

The company's devices are classified as Class I and are listed in the FDA UDI registry. Oftal-One Inc is based in the United States.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

Company details

FDA FEI number
3016248648
Address
250 Catalonia Ave, Coral Gables, FL, 33134

Frequently asked questions

How many devices does OFTAL-ONE INC have in the registry?

The registry currently lists 6 devices for OFTAL-ONE INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list OFTAL-ONE INC's devices?

Among its 6 most recently registered devices, OFTAL-ONE INC has devices listed in FDA GUDID (6 devices).

What risk classes do OFTAL-ONE INC's devices fall under?

Among its 6 most recently registered devices, the classes recorded for OFTAL-ONE INC's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from OFTAL-ONE INC in the registry?

The most recently registered devices listed for OFTAL-ONE INC include OftalOnePack, Oftal-One PASC 001PK, OftalOnePack, Oftal-One PAEX 001PK, OftalOnePack, Oftal-One PAEN 001PK and OftalOnePack PAPR 001N.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.