Carl Zeiss Meditec (Suzhou) Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 4 device types, 3 products catalogued.
Carl Zeiss Meditec (Suzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Microscope, Surgical, Light-Induced Fluorescence Caries Detector and 2 other device types. 3 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 | 3032734659 |
| FEI number | 3032734659 |
| DUNS | 631835173 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 4F, No.26 Wu Sheng Road, SIP |
| Postal code | 215126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Light-Induced Fluorescence Caries Detector | Class 2 | Fluorescence mode | 2025 | 1 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | Class 1 | S100 / OPMI pico i, S7 / Opmi Visu 160, S8 / OPMI Lumera T, S8/OPMI Visu 200, S81 / OPMI Lumera T, S7 / OPMI Lumera and 18 more | 2011 | 12 |
| Microscope, Surgical | Class 1 | EXTARO 300; Reusable Asepsis Caps | 2005 | 9 |
| Microscope, Surgical, General & Plastic Surgery | Class 1 | S7 / OPMI PROergo and accessories, S7 / OPMI Sensera and accessories, OPMI PENTERO 800 and accessories, S100 / OPMI pico and accessories, KINEVO 900 and accessories, Blue 400 and 5 more | 2005 | 11 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Extaro 300 | EPT | 6 |
| Opmi Lumera 300 | FSO | 1 |
| Fluorescence Mode | NBL | 1 |
Clearances
No clearance names Carl Zeiss Meditec (Suzhou) Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K171007 | 2018-05-03 | NBL | Traditional | Carl Zeiss Suzhou Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 13,000 square meters |
|---|---|
| Main products | Ophthalmology equipment, Microsurgery systems |
| Certifications | FDA |
| 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.
The manufacturer named here can complete this record.