Harry Lei

FDA Filings

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

FDA Registration(s)
Registration Number3009279940
FEI Number3009279940
NameHarry Lei
Owner & OperatorDAHONG OPTICAL (XIAMEN) CO., LTD.
Contact Address2002 JIETOU ROAD XIANGAN DISTRICT
XIAMEN CN-35 Fujian 361101 CN
Official Correspondent
  • Shu-His Hsu
  • 86-592-7168585-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2060 S Haven Ave
Ontario, CA 91761 US
Establishment TypeManufacture Medical Device

Registration Number3010526253
FEI Number3010526253
NameHarry Lei
Owner & OperatorPRO CHAMP LTD.
Contact Address7F., 50, Chang-An East Road Sec. 2
Taipei TW-TPE Taipei - Special Municipality 202 TW
Official Correspondent
  • Jack Wu
  • 886-2-25511212-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2060 S Haven Ave
Ontario, CA 91761 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Harry Lei [PRO CHAMP LTD.]
SafetyVu2019-08-20
Harry Lei [PRO CHAMP LTD.]
Renegade2019-08-20
Harry Lei [PRO CHAMP LTD.]
Sharp Vision2017-08-10
Harry Lei [PRO CHAMP LTD.]
Renegade2017-08-10
Harry Lei [PRO CHAMP LTD.]
NIRTECH2017-08-10
Harry Lei [PRO CHAMP LTD.]
7eye2017-08-10
Harry Lei [PRO CHAMP LTD.]
Sharp Vision2017-08-10
Harry Lei [PRO CHAMP LTD.]
Renegade2017-08-10
Harry Lei [PRO CHAMP LTD.]
NIRTECH2017-08-10
Harry Lei [PRO CHAMP LTD.]
7eye2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Sharp Vision2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Renegade2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
NIRTECH2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
7eye2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Renegade2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
ONOS2017-08-10
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
7eye2017-08-10
Harry Lei [PRO CHAMP LTD.]
Berkley2014-08-01
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Octo2014-03-17
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Safetyvu2014-03-17
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Berkley2014-03-17
Harry Lei [PRO CHAMP LTD.]
Veer2013-11-25
Harry Lei [PRO CHAMP LTD.]
Safetyvu2013-11-25
Harry Lei [DAHONG OPTICAL (XIAMEN) CO., LTD.]
Berkley2012-01-31

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