Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008311916

FEI Number

3008311916

Entity Name

VR MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

KUNSHAN Jiangsu, CN

Establishment Address

No. 90 GAOXIN RD, ZHOUZHUANG, KUNSHAN Jiangsu 215325, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VR MEDICAL TECHNOLOGY CO., LTD. (Owner Number: 10031862)

Owner / Operator Contact Address

No. 90 GAOXIN RD, ZHOUZHUANG, KUNSHAN, CN-JS 215325, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kentec VR MEDICAL Dynarex, TwinMed,Medline Deroyal opti air Kentec Safe BVM Kentec Dynarex, TwinMed VR MEDICAL, Deroyal Dynarex, TwinMed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-01-22
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2019-01-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2019-01-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-07-31
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2010-03-16
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2015-06-26
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2017-05-09
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-04-03
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-11-29
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2024-12-18
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2011-05-17
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-06-26
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2012-04-03
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2016-12-17

Official Correspondent

LEE PAN

US Agent Details

Shunyi Zhang Email: syzhang@vrmedical.net Phone: (626) 2275727

Related Public Records

Same Entity

VR MEDICAL TECHNOLOGY CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008311916. Last updated year: 2026. Please use registration number 3008311916 when referencing this establishment in official correspondence.