Carl Zeiss Suzhou Co L T D

FDA Filings

This page includes the latest FDA filings for Carl Zeiss Suzhou 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: 3008564898
• FEI Number: 3008564898
• Name: Carl Zeiss Suzhou Co., Ltd.
• Owner & Operator: Carl Zeiss Inc.
• Contact Address: 1 North Broadway ; White Plains NY 10601 US
• US Agent:
  • Scott Margolin
  • Carl Zeiss, Inc.
  • 914 6817880
  • scott.margolin@zeiss.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Modern Industrial Square 3B No. 333 Xing Pu Road; SIP, Suzhou Jiangsu, 215126 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06909262100104 Carl Zeiss Suzhou Co., Ltd.	EXTARO® 300	2022-08-19
GUDID 06909262061375 Carl Zeiss Suzhou Co., Ltd.	OPMI® LUMERA® 300	2022-08-19
GUDID 06909262060354 Carl Zeiss Suzhou Co., Ltd.	EXTARO® 300	2022-08-19
GUDID 06909262060347 Carl Zeiss Suzhou Co., Ltd.	EXTARO® 300	2022-08-19
GUDID 06909262060330 Carl Zeiss Suzhou Co., Ltd.	EXTARO® 300	2022-08-19
GUDID 06909262200477 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axiolab 430037-9120-000	2021-01-11
GUDID 06909262200460 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axiolab 430037-9110-000	2021-01-11
GUDID 06909262200422 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axioscope 430035-9261-000	2021-01-11
GUDID 06909262200378 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axioscope 430035-9201-000	2021-01-11
GUDID 06909262200330 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axioscope 430035-9061-000	2021-01-11
GUDID 06909262200323 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axioscope 430035-9032-000	2021-01-11
GUDID 06909262200316 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axio Lab 430037-9000-000	2021-01-11
GUDID 06909262200293 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axiolab 430037-9070-000	2021-01-11
GUDID 06909262200286 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axiolab 430037-9060-000	2021-01-11
GUDID 06909262200248 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axiolab 430037-9021-000	2021-01-11
GUDID 06909262200231 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axiolab 430037-9011-000	2021-01-11
GUDID 06909262200125 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axio Lab 430037-9020-000	2021-01-11
GUDID 06909262200118 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axio Lab 430037-9010-000	2021-01-11
GUDID 06909262200064 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axio Vert 431030-9040-000	2021-01-11
GUDID 06909262200057 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axio Vert 431030-9010-000	2021-01-11
GUDID 06909262200040 Carl Zeiss Suzhou Co., Ltd.	ZEISS Axio Vert 431030-9000-000	2021-01-11
GUDID 06909262100043 Carl Zeiss Suzhou Co., Ltd.	Fluorescence Mode 000000-2165-387	2019-04-29
PMN K171007 | NBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Fluorescence	2018-06-11
PMN K171007 Carl Zeiss Suzhou Co., Ltd.	Fluorescence Mode	2018-05-03
PMN K163195 Carl Zeiss Suzhou Co., Ltd.	PRIMUS	2017-06-21
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 508	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery.V8	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiovert .A1	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Observer	2016-08-11
MTX Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Lab.A1	2016-08-11
HOO Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Humphrey FDT Model 710	2012-04-25
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Lab A1	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primovert	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primovert iLED	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBL Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Observer	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO LUMAR	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V8	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V20	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V12	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Lab A1	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBK Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SterREO Discovery V12	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi DV4	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 508	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 2000	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 2000 CS	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Stemi 2000 C	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Lumar V12	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V20	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	SteREO Discovery V.8	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Primo Star & Primo Star iLED	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	PRIMO STAR	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 7	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axioscope 5	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axiolab 5	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Vert A1	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Scope A1	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager OEM	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M2p	2005-03-15
IBJ Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Axio Imager M1	2005-03-15
HRM Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	OPMI LUMERA 300	1992-12-18
FSO Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	OPMI LUMERA 300	1992-12-18
EPT Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	Reusable Asepsis Caps	1992-12-18
EPT Carl Zeiss Suzhou Co., Ltd. [Carl Zeiss Inc.]	EXTARO 300	1992-12-18

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020083140635	Shanghai ,China (Mainland) -> Oakland, California	PLASTIC SHAFT	3 PKG
2020080722569	Shanghai ,China (Mainland) -> Oakland, California	PLASTIC COVER	2 PKG
2020080334430	Shanghai ,China (Mainland) -> Oakland, California	PLASTIC COVER	2 PKG
2020061315749	Shanghai ,China (Mainland) -> Oakland, California	CAMERA	3 PKG
2020060514875	Shanghai ,China (Mainland) -> Oakland, California	CAMERA	3 PKG
2020052221745	Shanghai ,China (Mainland) -> Oakland, California	PLASTIC SHAFT	2 PKG