Data / Medical devices / China / VR Medical Technology Co., Ltd.
VR Medical Technology Co., Ltd.: FDA-registered device maker in KUNSHAN Jiangsu, China, 8 510(k) clearances
VR Medical Technology Co., Ltd. is registered with the FDA (registration 3008311916) in KUNSHAN Jiangsu, China. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008311916
- Address
- No. 90 GAOXIN RD ZHOUZHUANG, KUNSHAN Jiangsu, China, 215325
- Owner or operator
- VR MEDICAL TECHNOLOGY CO., LTD. (10031862)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 16, 2010
- Registered through
- 2026
- Brand names listed
- Deroyal, Dynarex, TwinMed, Dynarex, TwinMed,Medline, Kentec, Safe BVM, VR MEDICAL, VR MEDICAL, Deroyal, opti air 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 |
|---|---|---|---|---|---|---|
| January 18, 2019 | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | FPD | Substantially Equivalent | Vr Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 28, 2017 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | OMP | Substantially Equivalent | Vr Medical Technologies, LLC | accessdata.fda.gov |
| September 22, 2016 | K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) | PNR | Substantially Equivalent | Vr Medical Technology | accessdata.fda.gov |
| July 30, 2014 | K132709 | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | CAH | Substantially Equivalent | Vr Medical | accessdata.fda.gov |
| February 17, 2012 | K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET | KNT | Substantially Equivalent | Kentec Medical, Inc. | accessdata.fda.gov |
| February 10, 2012 | K110078 | EXTRICARE | OMP | Substantially Equivalent | Devon Medical Products, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110853 | VR MEDICAL ENTERAL ORAL SYRINGE | FPD | Substantially Equivalent | Vr Medical | accessdata.fda.gov |
| April 22, 2010 | K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | FPD | Substantially Equivalent | Kentec Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Feeding
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Dispenser, Liquid Medication
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
Updated January 18, 2019. 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.