VR Medical Technology Co., Ltd.
Manufacturer and brand owner in Kunshan, Jiangsu, China. 13 device types, 16 products catalogued, 5 clearances.
VR Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Tube, Feeding, Catheter And Tip, Suction and 11 other device types. 16 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | VR MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008311916 |
| FEI number | 3008311916 |
| DUNS | 420798349 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 昆山韦睿医疗科技有限公司 |
|---|---|
| Unified social credit code | 913205836979165600 |
| Source | NMPA UDI database |
Location
| City | Kunshan |
|---|---|
| Province | Jiangsu |
| Address | No. 90 GAOXIN RD |
| Postal code | 215325 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter And Tip, Suction | Class 2 | Dynarex, TwinMed | 2015 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | Dynarex, TwinMed | 2014 | 93 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | Dynarex, TwinMed, opti air, twinmed | 2010 | 29 |
| Device, Fixation, Tracheal Tube | Class 1 | Dynarex, TwinMed | 2016 | 46 |
| Dispenser, Liquid Medication | Class 1 | VR Medical | 2010 | 86 |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | Kentec | 2016 | 13 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | 2014 | 15 | |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Kentec | 2019 | 17 |
| Negative Pressure Wound Therapy Powered Suction Pump | Class 2 | VR MEDICAL, Deroyal, Deroyal | 2012 | 8 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Dynarex, TwinMed,Medline | 2015 | 51 |
| Tube, Feeding | Class 2 | Kentec | 2011 | 3 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | opti air, Kentec | 2012 | 25 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | Safe BVM | 2024 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Closed Suction System | BYD | 7 |
| VR Medical Technology Co., Ltd. | BSY | 4 |
| Heat and Moisture Exchanger with Suction Port | BYD | 4 |
| Heat and Moisture Exchanger Filter with Gas Sampling Port | CAH | 3 |
| Heat and Moisture Exchanger with Gas Sampling Port | BYD | 2 |
| Heat and Moisture Exchanger Filter | CAH | 2 |
| Closed Suction System for Adult | BSY | 1 |
| Heat and Moisture Exchanger Filter with Flexible Tube | CAH | 1 |
| Heat Moisture Exchanger and Filter | CAH | 1 |
| Adult Flex Tubing | BZO | 1 |
| Heat and Moisture Exchanger | BYD | 1 |
| HEPA Breathing Filter | CAH | 1 |
| Breathing Filter | CAH | 1 |
| Pediatric Flex Tubing | BZO | 1 |
| Heat and Moisture Exchanger Integrted Flex Tube | BYD | 1 |
| Heat Moisture Exchanger and Filter | BYD | 1 |
Clearances
5 clearances name VR Medical Technology Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K180236 | 2019-01-18 | FPD | Traditional | This company |
| K162159 | 2017-04-28 | OMP | Traditional | This company |
| K162188 | 2016-09-22 | PNR | Traditional | This company |
| K132709 | 2014-07-30 | CAH | Traditional | This company |
| K110853 | 2011-05-13 | FPD | Traditional | This company |
| K120272 | 2012-02-17 | KNT | Traditional | Kentec Medical, LLC |
| K110078 | 2012-02-10 | OMP | Traditional | Devon Medical Products |
| K100526 | 2010-04-22 | FPD | Traditional | Kentec Medical, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Main products | blood purification devices, wound care products, respiratory care devices, dialysis equipment |
| Certifications | FDA registered, ISO 13485 |
| Export markets | United States, Europe, South America, Asia |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.