Data / Medical devices / China / Carl Zeiss Meditec (Suzhou) Co., Ltd.
Carl Zeiss Meditec (Suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Carl Zeiss Meditec (Suzhou) Co., Ltd. is registered with the FDA (registration 3032734659) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 3, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032734659
- Address
- 4F, No.26 Wu Sheng Road, SIP, Suzhou Jiangsu, China, 215126
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Manufacturer
- First device listed
- June 3, 2005
- Registered through
- 2026
- Brand names listed
- ARTEVO 750/850, ARTEVO 800, BLUE 400, EXTARO 300; Reusable Asepsis Caps, Fluorescence mode, KINEVO 900 S, KINEVO 900 and accessories, OPMI 1 FR pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light-Induced Fluorescence Caries Detector | NBL | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2018 | K171007 | Fluorescence Mode | NBL | Substantially Equivalent | Carl Zeiss Suzhou Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Microscope, Surgical, General & Plastic Surgery
- All makers of Light-Induced Fluorescence Caries Detector
- All makers of Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- All makers of Microscope, Surgical
Updated May 3, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.