Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008564898

FEI Number

3008564898

Entity Name

Carl Zeiss Suzhou Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.26 Wusheng Road, SIP, Suzhou Jiangsu 215126, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Carl Zeiss Inc. (Owner Number: 2431026)

Owner / Operator Contact Address

1 North Broadway, White Plains, NY 10601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Axiovert 5 Primostar 1 Axio Vert A1 Primovert iLED Primovert Axio Observer Primo Star / Primo Star iLED Axioscope 7 Stemi 508 SteREO Discovery V8 Axio Imager M1 Axiovert 5 SteREO Lumar V12 Axio Imager M2p Axioscope 5 Axio Imager OEM SteREO Discovery V12 Primostar 3 Axio Vert A1 Axio Imager 2 Primostar 1 Stemi DV4 Axiolab 5 Axio Scope A1 Stemi 2000 / 2000 C / 2000 CS SteREO Discovery V20 Axio Lab A1 Primo Star / Primo Star iLED Axio Imager M1 Axiovert 5 Axioscope 5 Axiolab 5 Axioscope 7 Primostar 1 Axio Imager M2p Axio Imager OEM Axio Imager 2 Axio Scope A1 Primostar 3 Axio Vert A1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IBL	Microscope, Inverted Stage, Tissue Culture	Pathology	Class 1	864.3600	2005-03-15
IBM	Microscope, Phase Contrast	Pathology	Class 1	864.3600	2005-03-15
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2005-03-15

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Margolin Business: CARL ZEISS INC. Email: scott.margolin@zeiss.com Phone: (914) 6817880

Related Public Records

Same Entity

Carl Zeiss Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8010666	Carl Zeiss Microscopy, GmbH	Jena Thuringia, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008564898. Last updated year: 2026. Please use registration number 3008564898 when referencing this establishment in official correspondence.