Data / Medical devices / United States / The Ruhof Corporation
The Ruhof Corporation: FDA-registered device maker in Mineola, NY, United States, 7 510(k) clearances
The Ruhof Corporation is registered with the FDA (registration 3003207991) in Mineola, NY, United States. It lists 14 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003207991
- Address
- 393 Sagamore Ave, Mineola, NY, United States, 11501
- Owner or operator
- The Ruhof Corporation (10038187)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 22, 2011
- Registered through
- 2026
- Brand names listed
- 345CKENT Custom Kit, 345CVTK, 345EBK500 345EBKNA500 G4SVECOLRF 345EBK, 345PTC100, 345SVECOS, 345SVV04, 345SVVO4, 345SVVO5 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2023 | K232118 | ANDORATE® Valve Kit | ODC | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| August 18, 2022 | K212856 | iClean Viral Transport System (VTM-RT kit) | JSM | Substantially Equivalent | Huachenyang (Shenzhen) Technology Co. , Ltd. | accessdata.fda.gov |
| April 17, 2019 | K182998 | Andorate Auxiliary Water Connector | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| July 6, 2018 | K181509 | Endorate Valve Sets | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| December 3, 2015 | K151714 | Disposable Endoscope Valves Set A | ODC | Substantially Equivalent | Wilson Instruments (Shanghai) Company Limited | accessdata.fda.gov |
| May 17, 2013 | K122417 | SCOPEVALET DISPOSABLE BIOPSY VALVE | OCX | Substantially Equivalent | The Ruhof Corp. | accessdata.fda.gov |
| April 10, 2012 | K112110 | STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | Jianerkang Medical Dressing Company | accessdata.fda.gov |
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Updated October 16, 2023. 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.