Hochuen Medical Technology Co L T D

FDA Filings

This page includes the latest FDA filings for Hochuen Medical Technology Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013019728
• FEI Number: 3013019728
• Name: Simcal
• Owner & Operator: Hochuen Medical Technology Co.,Ltd.
• Contact Address: Building 2,ChungKin lnd.Estate,Huaxing R ; Shenzhen CN-44 Guangdong 518109 CN
• Official Correspondent:
  • Kevin Geng
  • 086-755-2814006-8
• US Agent:
  • Simcal
  • UCL-REG SERVICE INC.
  • 347 7030850
  • gbstandard@163.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3907 PRINCE STREET SUITE 6F ; Flushing, NY 11354 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
IOD Simcal [Hochuen Medical Technology Co.,Ltd.]	REAL Sensor Bands	2019-12-22
PMN K163636 | OZY Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OZX Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OZE Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OTG Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OQW Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OOU Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OEP Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OEM Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | OCC Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K163636 | NSU Simcal [Hochuen Medical Technology Co.,Ltd.]	ePlex? Respiratory Pathogen (RP) Panel	2017-12-18
PMN K162137 | FLL Simcal [Hochuen Medical Technology Co.,Ltd.]	Fever Scout? Continuous Monitoring Thermometer	2017-08-02

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082433555	Yantian,China (Mainland) -> Oakland, California	REAL SENSOR BANDS 20PACKAGES 480CARTONS	480 CTN
202008191763	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202008191763	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202008191763	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202008191763	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202008191763	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202008051444	Yantian,China (Mainland) -> Long Beach, California	OAKLEY FACE SHIELD KIT 3.0 40PACKAGES 40 PALL ETS	200 PCS
202008051444	Yantian,China (Mainland) -> Long Beach, California	OAKLEY FACE SHIELD KIT 3.0 40PACKAGES 40 PALL ETS	200 PCS
202008051444	Yantian,China (Mainland) -> Long Beach, California	OAKLEY FACE SHIELD KIT 3.0 40PACKAGES 40 PALL ETS	200 PCS
202008051444	Yantian,China (Mainland) -> Long Beach, California	OAKLEY FACE SHIELD KIT 3.0 40PACKAGES 40 PALL ETS	200 PCS
202008051444	Yantian,China (Mainland) -> Long Beach, California	OAKLEY FACE SHIELD KIT 3.0 40PACKAGES 40 PALL ETS	200 PCS
2020080345532	Yantian,China (Mainland) -> Oakland, California	REAL SENSOR BANDS 20PACKAGES 480CARTONS	20 PKG
202007315576	Yantian,China (Mainland) -> Long Beach, California	OAKLEY FACE SHIELD KIT 3.0 40PACKAGES 40 PALL ETS	40 PCS
2020072731356	Yantian,China (Mainland) -> Oakland, California	REAL SENSOR BANDS 20PACKAGES EQUAL 480CARTONS	480 CTN
202007211826	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202007211826	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202007211826	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202007211826	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
202007211826	Yantian,China (Mainland) -> Los Angeles, California	OAKLEY FACE SHIELD KIT 3.0 40 PALLETS 40PACKA GES	200 PCS
2020071819043	Yantian,China (Mainland) -> Oakland, California	REAL SENSOR BANDS 20PACKAGES 480CARTONS	480 CTN