Shandong Lewin Medical Equipment Co L T D

FDA Filings

This page includes the latest FDA filings for Shandong Lewin Medical Equipment 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 Number3011522441
FEI Number3011522441
NameFiona Chan
Owner & OperatorSHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.
Contact AddressNo.2 Fazhan Avenue Economic Development Zone
Qufu City CN-37 Shandong 273100 CN
Official Correspondent
  • Zhe Tao
  • 086-537-3748923-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6050 W EASTWOOD AVE APT 201
Chicago, IL 60630 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-17
Shandong Lewin Medical Equipment Co., Ltd.
LEWIN 2023-02-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LED280,LED300,LED380, CreLed 3100M2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Creled310M,Creled150M2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
AC-Powered medical examination light,LEWIN series Examination Light LED180,LED180Y,LED100,LED200,2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Table, Surgical With Orthopedic Accessories, Ac-Powered Examination Table, Obstetric Examination Bed CreLife 100,2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreLife 2000,CreLife 3000,CreLife 6000,CreLife 8000, LDF100,LDF200,LDF300,LDF-600A, LDF600B,LDF-800A,LDF-800B2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Surgical lamp, Crelite500, Crelite600, Crelite700, CreLite 500/ 500, CreLite 600/ 600, CreLite 700/ 500,2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Creled 150M2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreLite 700/ 700, CreLite 500/ 500/ 700, CreLite 500/ 700/ 700, CreLite 500M, CreLed 5700/5500,2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreLed 5700/5700/5500 with camera system,Creled3400/3400,Creled3300/3300,Hollow Creled5700/5700,Hollow Creled5500/55002016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreLed 5700/ 5700,Creled5500/5500,CreLed 5700/5700 with camera system2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreLed 5700, CreLed 5500, CreLed 5500M, CreLed 3400, CreLed 3300, CreLed 3400/3300, CreLed 3300M2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
TABLE, OPERATING-ROOM, AC-POWERED,Electric Operating Table, Electric Hydraulic Operating Table CreBle 1000,2016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreBle 1500,CreBle 2000, CreBle 2100, CreBle 6300, CreBle 3000, CreBle 8100, CreBle 91002016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreBle 1000,Creble 3500, Creble 5000, Creble55002016-01-14
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Light, Surgical, Ceiling mounted - Surgical Light2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LW700_500 with camera system, LED680, LED680_680,LED680_400, LED400, LED400_400, LED680_400 with camera system,2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LEWIN Series LW500,LWY500,LW600,LW700,LW500_500,LW600_600,LW700_700,LW700_500,LW700 with camera system,2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LED700_500 with camera system, LED780,LED780_780, LED580, LED580_580, LED580Y, LED780_580, LED780 with camera system,2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LED680 with camera system,LED700_500, LED700, LED700_700, LED500, LED500_500, LED500Y , LED700 with camera system,2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LED580 with camera system, LED780_580 with camera system, LED580_580 with camera system2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LED400Y2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LED 700/ 700 with camera system2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Table and Attachment,Operating Room2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LEWIN Series Manual Operating Table, Manual hydraulic operating table LST2000A, LST2000B, CreBle 200, CreBle 230,2014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
CreBle 330, CreBle 350, CreBle 530, CreBle 5502014-12-16
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
Table, Operating-Room, Electrical2014-12-02
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LEWIN series Electric Operating Table, Electric Hydraulic Operating Table, Electric Obstetric Exam Bed2014-12-02
Fiona Chan [SHANDONG LEWIN MEDICAL EQUIPMENT CO., LTD.]
LDT100A, LDT100B, LDT2000A,LDT2000B, LDT3000A, LDT3000B,LDT6000A,LDT6000B2014-12-02

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