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
| Country | Makers |
|---|---|
| United States | 7 |
| United Kingdom | 3 |
| Switzerland | 2 |
| China | 2 |
| Germany | 2 |
| Taiwan | 1 |
| Vietnam | 1 |
| Thailand | 1 |
| Sweden | 1 |
| Finland | 1 |
| Austria | 1 |
| Israel | 1 |
| India | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3M Company | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 1 | June 15, 1995 | 0 | 0 | 0 | api.fda.gov |
| Microlife Corp. | Taipei, Taiwan | Manufacturer | 1 | September 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Microlife Intellectual Property GMBH | Widnau Sankt Gallen, Switzerland | Specification developer | 1 | September 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Onbo Electronic (shenzhen) Co. Ltd. | SHENZHEN Guangdong, China | Manufacturer | 1 | September 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| ONFU electronics Co., LTD. | Trang Bom Dong Nai, Vietnam | Manufacturer | 1 | September 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Valley Electronics AG | Zurich, Switzerland | Manufacturer, Specification developer | 1 | April 20, 2006 | 0 | 0 | 0 | api.fda.gov |
| viO HealthTech Limited | Camberley Surrey, United Kingdom | Specification developer | 1 | August 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Apple Inc. | Cupertino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aqp One, Inc. | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech LLC | Wilmington, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clue By Biowink GMBH | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corintech Limited | Fordingbridge Hampshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dejanae Ray LLC | Mesquite, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hana Microelectronics Public Co.,ltd. | A. Muang Lamphun, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Naturalcycles Nordic AB | Stockholm, Sweden | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oura Health OY | Oulu Pohjois-Pohjanmaa, Finland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quanovate Tech Inc. | San Ramon, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steadysense GMBH | Raaba-Grambach Steiermark, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tempdrop Ltd. | Tel Aviv, Israel | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tq-Systems GMBH | Seefeld Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions Weobley Limited | Weobley Herefordshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UltraFactory - Ultrahuman Manufacturing Facility | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.