Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032734659

FEI Number

3032734659

Entity Name

Carl Zeiss Meditec (Suzhou) Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

4F, No.26 Wu Sheng Road, SIP, Suzhou Jiangsu 215126, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Carl Zeiss Meditec AG (Jena) (Owner Number: 9053564)

Owner / Operator Contact Address

Goeschwitzer Strasse 51-52, Jena, DE-TH 07745, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fluorescence mode S88 / OPMI Lumera T S8/OPMI VISU 200 S100 / OPMI pico i RESIGHT 500 (with acccessories) RESIGHT 700 (with accessories) S8 / OPMI Lumera T S7 / OPMI VISU 160 S81 / OPMI Lumera T S7 / OPMI Lumera S7 / OPMI VISU 140 OPMI Lumera 700 OPMI 1 FR pro ARTEVO 800 UC 3D Digital Upgrade Kit S8/OPMI VISU 160 S8/OPMI VISU 210 OPMI Lumera i S81/OPMI VISU 160 S88/OPMI VISU 160 S88/OPMI VISU 210 S81/OPMI VISU 210 ARTEVO 750/850 Single-use lenses for RESIGHT OPMI Lumera 300 EXTARO 300; Reusable Asepsis Caps OPMI PENTERO 800 and accessories S7 / OPMI PROergo and accessories S7 / OPMI Sensera and accessories S100 / OPMI pico and accessories BLUE 400 KINEVO 900 and accessories TIVATO 700 and accessories OPMI PENTERO 900 and accessories PENTERO 800 S KINEVO 900 S OPMI Lumera 300

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2025-06-18
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2011-12-08
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2005-06-03
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2005-06-03

Official Correspondent

Carl ZEISS Meditec AG (Jena)

US Agent Details

Paul Swift Business: Carl Zeiss Meditec USA Inc Email: fdaagent.med.us@zeiss.com Phone: (817) 9258507

Related Public Records

Same Entity

Carl Zeiss Meditec AG (Jena)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015534077	Carl Zeiss Meditec Digital Innovations Inc	Temple, TX, US
3010126268	Carl Zeiss Meditec Production, LLC.	Ontario, CA, US
2918630	CARL ZEISS MEDITEC INC	DUBLIN, CA, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE
3004467263	FCI SUD	MAPOU LECLEZIO GOODLANDS Riviere du Rempart, MU

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032734659. Last updated year: 2026. Please use registration number 3032734659 when referencing this establishment in official correspondence.