Dennis Xu

FDA Filings

This page includes the latest FDA filings for Dennis Xu. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003717263
FEI Number3003717263
NameDennis Xu
Owner & OperatorJiangsu Suyun Medical Materials Co., Ltd.
Contact AddressNo.18,Jinqiao Road, Dapu Industrial Park Lianyungang Economic Development Zone
Lianyungang CN-32 Jiangsu 222002 CN
Official Correspondent
  • Xu Guang Ning
  • 086-518-5476672-x
US Agent
Importing Logistics Registration
ImporterAvcor Health Care Products, Inc.
Address2750 113th Street, Suite 300
Grand Prairie, TX 75050 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr.
Raleigh, NC 27606 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3010220539
FEI Number3010220539
NameDennis Xu
Owner & OperatorCo-Innovation Biotech Co.,Ltd.
Contact AddressNo. 9 Baihe 3 street,Economic and Technological Development East Zone,
Guangzhou CN-44 Guangdong 510530 CN
Official Correspondent
  • Hong Feng
  • 86-20-82109823-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

Registration Number3011208843
FEI Number3011208843
NameDennis XU
Owner & OperatorSuzhou Temeirui Medical Products Co., Ltd.
Contact AddressNo. 699 Pingan Road Puzhuang Linju town Wuzhong District
Suzhou City CN-32 Jiangsu 215105 CN
Official Correspondent
  • Jian He
  • 86-512-65188818-x
US Agent
  • Dennis XU
  • 919 8590478
  • 919 8590478
  • ybx99@yahoo.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr. Raleigh
Raleigh, NC 27606 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3008062466
FEI Number3008062466
NameDennis Xu
Owner & OperatorSuzhou Colour-way New Material Co., Ltd.
Contact AddressNo. 20, Anmin Road, Huangdai Town Xiangcheng District
Suzhou CN-32 Jiangsu 215152 CN
Official Correspondent
  • Na Zhang
  • 86-512-65371065-x
US Agent
Importing Logistics Registration
ImporterPBJ Group LLC
AddressMiami, FL 33139
Miami Beach, FL 33139 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr. Raleigh, NC 27606, USA
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

Registration Number3011353016
FEI Number3011353016
NameDENNIS XU
Owner & OperatorHunan Accurate Bio-Medical Technology Co., Ltd.
Contact Address6th,Floor,Biyang Industrial Zone, Lijiac 410208 Changsha,Hunan Province,China
Changsha CN-43 Hunan 410208 CN
Official Correspondent
  • Li Zhang
  • 86-731-84118539-x
US Agent
Importing Logistics Registration
ImporterS&W TREND
Address104 WILSON AVE APT 4 PASADENA,CA 91106
Pasadena, CA 91106 UNITED STATES
Importing Logistics Registration
ImporterShenzhen Lingshang E-commerce Co., Ltd.
AddressLiuxianju Building 4, 703 Nanshan District Xili Street
Shenzhen, 518000 CHINA
SubdivisionCN-44
Importing Logistics Registration
ImporterThousandshores Inc.
Address33442 Western Avenue
,
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 PEPPERTON
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

Registration Number3014166838
FEI Number3014166838
NameDennis Xu
Owner & OperatorShenzhen Jamr Technology Co., Ltd.
Contact Address2nd Floor, A-building, No.2 Guiyuan Road Longhua New District
Shenzhen CN-44 Guangdong 518110 CN
Official Correspondent
  • Fu Sheng Luo
  • 86-755-8529205-8054
US Agent
Importing Logistics Registration
ImporterGuangzhou Saimiao Trade Co., Ltd.
AddressNo. 15-31 C306, Dongcun Section, Lianlu Road, Dalong Street,
Guangzhou, 511450 CHINA
SubdivisionCN-44
Importing Logistics Registration
ImporterJOICOM CORPORATION
Address7365 CARNELIAN ST STE 226 RANCHO CUCAMONGA
CUCAMONGA, 91730 CANADA
SubdivisionCA-NOTA
Importing Logistics Registration
ImporterNature Major Inc.
Address315 W 36th Street,
Manhattan, NY 10018 UNITED STATES
Importing Logistics Registration
ImporterNoto-Tech Electronics Co, Ltd.
AddressShengrui Building 3D, Longhua
Shenzhen, 518000 CHINA
SubdivisionCN-44
Importing Logistics Registration
ImporterShapa Inc
AddressPOB 997 Cupertino
Cupertino, CA 95014 UNITED STATES
Importing Logistics Registration
Importershenzhen aihe Electronics Co., Ltd
AddressLONGGANG District BANTIAN Street SHUNXING GONGYEQU E Buildin
shenzhen, 518000 CHINA
SubdivisionCN-44
Importing Logistics Registration
Importershenzhen chengcheng Electronics Co., Ltd
Addressshatoujiao Street shensha Road 112 jiangong Building 3301
shenzhen, 518000 CHINA
SubdivisionCN-44
Importing Logistics Registration
ImporterShenzhen Xiaowang Tech Co., Ltd.
AddressRoom 1305,Building.B, Caifugang, No. 1084 Baoyuan Road, Fuzh
Shenzhen, 51800 CHINA
SubdivisionCN-44
Importing Logistics Registration
Importershenzhenshi shizhou Technology Co., Ltd.
Addressfutian district huaqiangbei street huaqiangbei road jinmaoliduqun building 229B
shenzhen, 518000 CHINA
SubdivisionCN-44
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr.
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

Registration Number3008261717
FEI Number3008261717
NameDennis Xu
Owner & OperatorXiamen Compower Medical Tech. Co., Ltd.
Contact AddressUnit 301, No.16, Xianghong Road, Xiang' An Torch Industrial Zone,
Xiamen CN-35 Fujian 361101 CN
Official Correspondent
  • Lifen Chen
  • 086-133-06000572-x
US Agent
Importing Logistics Registration
Importertongue
AddressNo.16, Xianghong Road, XiangRoad, Xiang'an Torch Industrial
Xiamen, 361101 CHINA
Email Addressdcc@cpmedi.cn
Phone86 592 5799319
FAX86 592 5796765
Importer TypeAgent
SubdivisionCN-35
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr
Raleigh, NC 27606 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility

Registration Number3007360701
FEI Number3007360701
NameDennis Xu
Owner & OperatorMedwell Medical Products Co., Ltd.
Contact AddressFenglin Town, Dean County, Jiangxi Province, China
Dean County CN-36 Jiangxi 330400 CN
Official Correspondent
  • zhao jinming
  • 086-792-4670387-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr. Raleigh NC 27606
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

Registration Number3010452651
FEI Number3010452651
NameDennis Xu
Owner & OperatorXiamen Winner Medical Co., Ltd.
Contact Address4F, No. 98, Huli Industrial Park, Mei Xi
Xiamen CN-35 Fujian 361100 CN
Official Correspondent
  • Wu Qing
  • 86-592-7238368-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr.
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

Registration Number3014632157
FEI Number3014632157
NameDennis Xu
Owner & OperatorWeihai Shengjie Medical Technology Co.,Ltd
Contact AddressNo.58,Chuhe South Road,High-Tech Industr
Weihai CN-37 Shandong 264200 CN
Official Correspondent
  • Wang Huihui
  • 86-0631-5702066-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4004 Pepperton Dr. Raleigh, NC 27606, USA
Raleigh, NC 27606 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Dennis XU [Suzhou Temeirui Medical Products Co., Ltd.]
Disposable Medical Face Mask2020-04-12
Dennis XU [Suzhou Temeirui Medical Products Co., Ltd.]
protective clothing2020-04-12
Dennis XU [Suzhou Temeirui Medical Products Co., Ltd.]
Disposable Isolation Gowns2020-04-12
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
FACE SHIELD, PROTECTIVE, ISOLATION MASK2020-03-26
Dennis Xu [Medwell Medical Products Co., Ltd.]
Disposable Medical Mask2020-03-25
Dennis Xu [Weihai Shengjie Medical Technology Co.,Ltd]
Face Mask2020-03-24
Dennis Xu [Weihai Shengjie Medical Technology Co.,Ltd]
Disposable general Medical Face Mask (Non-Surgical)2020-03-24
Dennis Xu [Weihai Shengjie Medical Technology Co.,Ltd]
Face Mask2020-03-23
Dennis Xu [Weihai Shengjie Medical Technology Co.,Ltd]
Disposable general Medical Face Mask (Non-Surgical)2020-03-23
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
FACE SHIELD, PROTECTIVE, ISOLATION MASK2020-03-21
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
EYE, PROTECTIVE, EYEWEAR, GOGGLES2020-03-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Safety goggles2020-03-18
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Non-rebreathing Mask2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
DRAIN BAG2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
HEAD WEDGE2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
ATOMIZER2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
BREATHING CIRCUIT2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Gas Tube2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Mouthpiece2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
VENTURI MASK2019-10-23
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
RESERVOIR BAG2019-10-23
Dennis Xu [Jiangsu Suyun Medical Materials Co., Ltd.]
URO Saf-Gard Extension Tubing2019-08-19
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Breath-Alcohol Test System2018-11-12
Dennis Xu [Suzhou Colour-way New Material Co., Ltd.]
Radiation Protection Gloves2018-10-09
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Cardiopulmonary Resuscitation Aid Kit, with CPR Mask2018-06-27
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Mouth Opener2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Cervical Collar2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Air Splint2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Airway, Oropharyngeal Airway2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Oxygen Mask2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Nose Clip2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Headgear2018-06-21
Dennis Xu [Xiamen Winner Medical Co., Ltd.]
Anesthesia mask2018-06-21
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
Pulse oximeter HS10A2018-04-10
Dennis Xu [Shenzhen Jamr Technology Co., Ltd.]
Digital Blood Pressure Monitor2018-02-13
Dennis Xu [Shenzhen Jamr Technology Co., Ltd.]
B02(RP-BPM002),B05,B06T,B07,B15,B02T,B51,B22(B21,B23),B26,B66T,B63,B562018-02-13
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Personal Protection Kit, glove2017-12-17
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Cardiopulmonary Resuscitation Aid Kit, with CPR Mask2017-12-17
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Pad, alcohol, device disinfectant, alcohol pad2017-12-17
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Non-Rebreathing Valve (18.5mm)2017-12-06
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Non-Rebreathing Valve (15mmOD)2017-12-06
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Infant CPR Mask with Oxygen Port2017-12-06
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
CPR Mask without Oxygen Port2017-12-06
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
CPR Mask with Oxygen Port2017-12-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
OPI Test Strip2017-09-17
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
THC Test Strip2017-08-31
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
THC Test Cassette2017-08-31
Dennis Xu [Medwell Medical Products Co., Ltd.]
Kit, surgical instrument, disposable, drape, table cover, mayo cover2017-03-13
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2016-05-03
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2016-05-03
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2016-05-03
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
tongue2015-07-28
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Syringe2015-03-16
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
Pulse oximeter2015-01-04
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P;2015-01-04
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
FS10A,FS20A,FS10C,FS20C,FS10D,FS20D,FS10E,FS20E,HS10A,HS20A,2015-01-04
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
Pulse Oximeter; Pulse Oximeter FS10C and FS20C; Pulse Oximeter FS10D and FS20D2014-12-16
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P;2014-12-16
DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]
Pulse Oximeter FS10E and FS20E2014-12-16
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
CO-INNOVATION2014-08-28
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
CO-INNOVATION2014-08-28
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
CO-INNOVATION2014-08-28
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
CO-INNOVATION2014-08-28
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
CO-INNOVATION2014-08-28
Dennis XU [Suzhou Temeirui Medical Products Co., Ltd.]
CINCH PAD2014-07-23
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-Innovation2014-07-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-Innovation2014-07-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-Innovation2014-07-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-Innovation2014-07-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-Innovation2014-07-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-Innovation2014-07-06
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2014-01-22
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2014-01-22
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2014-01-22
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2014-01-22
Dennis Xu [Co-Innovation Biotech Co.,Ltd.]
Co-innovation2014-01-22
Dennis Xu [Medwell Medical Products Co., Ltd.]
GOWN, SURGICAL2013-12-25
Dennis Xu [Suzhou Colour-way New Material Co., Ltd.]
Powdered Latex Surgeon's Glove2013-09-11
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Headgear2013-05-28
Dennis Xu [Jiangsu Suyun Medical Materials Co., Ltd.]
suction catheter; suction catheter kit2013-01-11
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
OXYGEN MASK2013-01-08
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Venturi Mask2013-01-08
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Oropharyngeal Airway2012-04-10
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Nose Clip2012-04-10
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Mouth Opener2012-04-08
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Tissue Cassettes2011-08-15
Dennis Xu [Jiangsu Suyun Medical Materials Co., Ltd.]
Disposable Endometrial Suction Curette2011-04-28
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Rescue mask2010-03-01
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Non-Rebreathing mask2010-03-01
Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]
Anesthesia mask2010-03-01
Dennis Xu [Suzhou Colour-way New Material Co., Ltd.]
m. Dior2009-11-08
Dennis Xu [Jiangsu Suyun Medical Materials Co., Ltd.]
gynaecological collector2009-07-13
Dennis Xu [Medwell Medical Products Co., Ltd.]
CUSHION, PAD, DENTURE, WAX IMPREGNATED COTTON, OVER THE COUNTER2008-11-12
Dennis Xu [Medwell Medical Products Co., Ltd.]
Gauze/sponge,nonresorbable for external use2008-11-12
Dennis Xu [Medwell Medical Products Co., Ltd.]
Fluff Gauze Roll2008-11-12
Dennis Xu [Medwell Medical Products Co., Ltd.]
Lap Sponge with X-ray detectable2008-11-12
Dennis Xu [Medwell Medical Products Co., Ltd.]
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2008-11-12
Dennis Xu [Medwell Medical Products Co., Ltd.]
SCALE, SURGICAL SPONGE2008-11-12
Dennis Xu [Medwell Medical Products Co., Ltd.]
COTTON, ROLL2008-11-12

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