Wendy

FDA Filings

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

FDA Registration(s)
Registration Number3015457586
FEI Number3015457586
NameWendy
Owner & OperatorFu'an Yunshan Electronics Co., Ltd.
Contact AddressNo.155, Shangcun, Qinxiyang Industrial Z
Fu'an CN-35 Fujian 355000 CN
Official Correspondent
  • Chang Lin
  • 86-0593-6395018-x
US Agent
  • Wendy
  • 518 3342827
  • yangiai@163.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address117 Essex Circle Apt D,Guilderland
Guilderland, NY 12084 US
Establishment TypeManufacture Medical Device

Registration Number0
FEI Number0
NameWendy
Owner & OperatorGUANGZHOU KIRIN GARMENT CO.,LTD
Contact AddressNo.11 FENGXIANG MIDDLE ROAD,JIANGGAO TOW
GUANGZHOU CN-44 Guangdong 510450 CN
Official Correspondent
  • XIAOHONG LI
  • 86-020-8616382-x
US Agent
  • Wendy
  • 518 3342827
  • yangiai@163.com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address117 Essex Circle Apt D
Guilderland, NY 12084 US
Establishment TypeManufacture Medical Device

Registration Number0
FEI Number0
NameWendy
Owner & OperatorJiangxi Longcheng Medical Instrument LTD.
Contact AddressSouth of Yuehua road,Chengnan Industrial
Ji'an CN-36 Jiangxi 331409 CN
Official Correspondent
  • Yangfang Liu
  • 86-0796-3710966-x
US Agent
  • Wendy
  • 518 3342827
  • Yangiai@163.Com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address117 Essex Circle Apt D
Guilderland, NY 12084 US
Establishment TypeManufacture Medical Device

Registration Number0
FEI Number0
NameWendy
Owner & OperatorNine Five Protection Technology Co., Ltd.
Contact AddressNo.3 Jinchai Road, Niuyang Community, Li
Dongguan CN-44 Guangdong 523429 CN
Official Correspondent
  • Guomin Zhang
  • 86-0769-81208080-x
US Agent
  • Wendy
  • 518 3342827
  • yangiai@163.com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address117 Essex Circle Apt D Guilderland Guilderland
Guilderland, NY 12084 US
Establishment TypeManufacture Medical Device

Registration Number0
FEI Number0
NameWendy
Owner & OperatorFUJIAN XINLI PAPER INDUSTRY CO., LTD
Contact AddressNo. 19, Quanyuan Road, Wuli Industry, Ji
Quanzhou CN-35 Fujian 362200 CN
Official Correspondent
  • Yanxia Zhang
  • 86-0595-88186388-x
US Agent
  • Wendy
  • 518 3342827
  • Yangiai@163.Com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address201 Essex Circle Apt D
Guilderland, NY 12084 US
Establishment TypeManufacture Medical Device

Registration Number0
FEI Number0
NameWendy
Owner & OperatorYu-Huang Electronics Dongguan Co., Ltd.
Contact AddressBuilding A4, Zhenxing Technology Park, F
Dongguan CN-44 Guangdong 523581 CN
Official Correspondent
  • Yuqiang Su
  • 86-0769-86910666-x
US Agent
  • Wendy
  • 518 3342827
  • Yangiai@163.Com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address17 Essex Circle Apt D
Guilderland, NY 12084 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Wendy [GUANGZHOU KIRIN GARMENT CO.,LTD]
Mask2020-04-09
Wendy [GUANGZHOU KIRIN GARMENT CO.,LTD]
KN95 Mask2020-04-09
Wendy [GUANGZHOU KIRIN GARMENT CO.,LTD]
KN Mask2020-04-09
Wendy [Yu-Huang Electronics Dongguan Co., Ltd.]
N95 Protective mask2020-04-08
Wendy [Yu-Huang Electronics Dongguan Co., Ltd.]
KN95 Protective mask2020-04-08
Wendy [FUJIAN XINLI PAPER INDUSTRY CO., LTD]
Disposable mask2020-04-07
Wendy [Nine Five Protection Technology Co., Ltd.]
KN95 Mask2020-03-28
Wendy [Jiangxi Longcheng Medical Instrument LTD.]
Daily Protective Face Mask2020-03-22
Wendy [Nine Five Protection Technology Co., Ltd.]
High protective one-time-use masks2020-03-21
Wendy [GUANGZHOU KIRIN GARMENT CO.,LTD]
Disposable mask2020-03-21
Wendy [Fu'an Yunshan Electronics Co., Ltd.]
Head Massager2019-04-24
Wendy [Fu'an Yunshan Electronics Co., Ltd.]
Eyes Massager2019-04-24
Wendy [Fu'an Yunshan Electronics Co., Ltd.]
Electric Massage Stick2019-04-24
Wendy [Fu'an Yunshan Electronics Co., Ltd.]
Electric Massage Pillow2019-04-24
Wendy [Fu'an Yunshan Electronics Co., Ltd.]
Electric Back & Neck Massager2019-04-24

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092981843Yantian,China (Mainland) -> Los Angeles, CaliforniaSHIRT TOP APPAREL1 PCS
2020092984148Yantian,China (Mainland) -> Los Angeles, CaliforniaSHIRT TOP APPAREL1 PCS
2020092985505Yantian,China (Mainland) -> Los Angeles, CaliforniaSHIRT TOP APPAREL1 PCS
2020092993142Yantian,China (Mainland) -> Los Angeles, CaliforniaPLUMBING SUPPLY1 PCS
2020092994648Yantian,China (Mainland) -> Los Angeles, CaliforniaSHIRT TOP APPAREL1 PCS
2020092989377Yantian,China (Mainland) -> Los Angeles, CaliforniaSWEATER APPAREL1 PCS
2020092987735Yantian,China (Mainland) -> Los Angeles, CaliforniaSWEATER APPAREL1 PCS
2020092990337Yantian,China (Mainland) -> Los Angeles, CaliforniaSHIRT TOP APPAREL1 PCS
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