Carl Zeiss Suzhou Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 5 device types, 10 products catalogued, 2 clearances.
Carl Zeiss Suzhou Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Light, Microscope, Microscope, Phase Contrast and 3 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008564898 |
| FEI number | 3008564898 |
| DUNS | 528182577 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.26 Wusheng Road |
| Postal code | 215126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Light, Microscope | Class 1 | Primostar 3, Axio Vert A1, Axio Lab A1, Axioscope 5, Primo Star / Primo Star iLED, Axiovert 5 and 8 more | 2005 | 19 |
| Microscope And Microscope Accessories, Reproduction, Assisted | Class 1 | Primo Star / Primo Star iLED, Primostar 1, Axiovert 5, Axiolab 5, Primostar 3, Axio Vert A1 and 1 more | 2016 | 4 |
| Microscope, Fluorescence/U.V. | Class 1 | Primo Star, Axio Scope A1, Axiolab 5, Primo Star iLED, Axio Lab A1, Axioscope 5 and 13 more | 2005 | 7 |
| Microscope, Inverted Stage, Tissue Culture | Class 1 | Primovert, Axiovert 5, Axio Vert A1, Primostar 1, Axio Observer, Primovert iLED | 2005 | 7 |
| Microscope, Phase Contrast | Class 1 | SteREO Discovery V8, Axioscope 7, Axio Scope A1, Axiovert 5, Primostar 3, Axio Imager M1 and 14 more | 2005 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Zeiss Primostar 3 | MTX | 11 |
| Zeiss Axiolab | MTX | 7 |
| Zeiss Axioscope | MTX | 4 |
| Extaro® 300 | EPT | 4 |
| Zeiss Axiovert | MTX | 3 |
| Zeiss Axio Lab | MTX | 3 |
| Zeiss Axio Vert | MTX | 3 |
| Zeiss Primostar 1 | MTX | 2 |
| Fluorescence Mode | NBL | 1 |
| Opmi® Lumera® 300 | FSO | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K171007 | 2018-05-03 | NBL | Traditional | This company |
| K163195 | 2017-06-21 | OBO | Traditional | This company |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-08-18 | Class II | Process control | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components. | 8 |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 13000 m² (new R&D site opened 2024) |
|---|---|
| Main products | optical components, precision instruments |
| Export markets | global |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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