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Data / Medical devices / Device, Fertility Diagnostic, Proceptive

Device, Fertility Diagnostic, Proceptive (LHD): 24 FDA-registered makers in 13 countries

24 establishments in 13 countries are registered with the FDA to make Device, Fertility Diagnostic, Proceptive (product code LHD, Class U). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on January 19, 2021, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LHD
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
United States7
United Kingdom3
Switzerland2
China2
Germany2
Taiwan1
Vietnam1
Thailand1
Sweden1
Finland1
Austria1
Israel1
India1

Makers of Device, Fertility Diagnostic, Proceptive

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer1June 15, 1995000api.fda.gov
Microlife Corp.Taipei, TaiwanManufacturer1September 12, 2003000api.fda.gov
Microlife Intellectual Property GMBHWidnau Sankt Gallen, SwitzerlandSpecification developer1September 12, 2003000api.fda.gov
Onbo Electronic (shenzhen) Co. Ltd.SHENZHEN Guangdong, ChinaManufacturer1September 12, 2003000api.fda.gov
ONFU electronics Co., LTD.Trang Bom Dong Nai, VietnamManufacturer1September 12, 2003000api.fda.gov
Valley Electronics AGZurich, SwitzerlandManufacturer, Specification developer1April 20, 2006000api.fda.gov
viO HealthTech LimitedCamberley Surrey, United KingdomSpecification developer1August 6, 2013000api.fda.gov
Apple Inc.Cupertino, CA, United StatesManufacturer0000api.fda.gov
Aqp One, Inc.Garden Grove, CA, United StatesManufacturer0000api.fda.gov
Assure Tech LLCWilmington, DE, United StatesSpecification developer0000api.fda.gov
Clue By Biowink GMBHBerlin, GermanyManufacturer0000api.fda.gov
Corintech LimitedFordingbridge Hampshire, United KingdomContract manufacturer0000api.fda.gov
Dejanae Ray LLCMesquite, TX, United StatesManufacturer0000api.fda.gov
Hana Microelectronics Public Co.,ltd.A. Muang Lamphun, ThailandContract manufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Naturalcycles Nordic ABStockholm, SwedenComplaint file establishment, Manufacturer0000api.fda.gov
Oura Health OYOulu Pohjois-Pohjanmaa, FinlandComplaint file establishment, Manufacturer0000api.fda.gov
Quanovate Tech Inc.San Ramon, CA, United StatesSpecification developer0000api.fda.gov
Steadysense GMBHRaaba-Grambach Steiermark, AustriaManufacturer0000api.fda.gov
Tempdrop Ltd.Tel Aviv, IsraelManufacturer, Specification developer0000api.fda.gov
Tq-Systems GMBHSeefeld Bavaria, GermanyContract manufacturer0000api.fda.gov
Trelleborg Sealing Solutions Weobley LimitedWeobley Herefordshire, United KingdomContract manufacturer0000api.fda.gov
UltraFactory - Ultrahuman Manufacturing FacilityBangalore Karnataka, IndiaManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated January 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.