Skip to content

Bioself, Inc.

Country not established

Devices
3

What Bioself, Inc. makes

Bioself, Inc. manufactures fertility monitoring devices, including the BIOSELF 2000 Fertility Indicator, BIOSELF TM 110, and BIOSELF 101. These products are designed to assist in tracking reproductive cycles and identifying fertile windows for women.

The company’s portfolio consists of Class II devices under FDA regulations, with each product authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry and are intended for use in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Bioself 2000 Fertility Indicator Ref K904211

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Bioself Tm 110 Ref K843699

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Bioself 101 Ref K823209

    Active Regimes: 510(k) Registry: 510(k) Class:—

Frequently asked questions

How many devices does Bioself, Inc. have in the registry?

The registry currently lists 3 devices for Bioself, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioself, Inc.'s devices?

Among its 3 most recently registered devices, Bioself, Inc. has devices listed in FDA 510(k) (3 devices).

What are the newest devices from Bioself, Inc. in the registry?

The most recently registered devices listed for Bioself, Inc. include BIOSELF 2000 FERTILITY INDICATOR, BIOSELF TM 110 and BIOSELF 101.

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