Leica Instruments (Shanghai) Co., Ltd.
Registered establishment in Shanghai, China. 11 device types.
Leica Instruments (Shanghai) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Light, Microscope, Microtome, Rotary and 9 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006610913 |
| FEI number | 3006610913 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 10-11, Lane 89, Lichuan Road |
| Postal code | 201210 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bath, Flotation, Tissue | Class 1 | HI1210, HistoCore Water Bath M | 2017 | 6 |
| Device For Sealing Microsections | Class 1 | CV5030, HistoCore SPECTRA CV, HistoCore CHROMAX CV | 2017 | 2 |
| Dispensers, Paraffin | Class 1 | HistoCore Arcadia H, HistoCore Arcadia C | 2017 | 7 |
| Light, Microscope | Class 1 | DM2000 LED, DM3000 LED, DM2500, DM1000, DM3000, DM2500LED and 2 more | 2017 | 19 |
| Microscope, Fluorescence/U.V. | Class 1 | DM1000, DM2500, DM2000 LED, DM2000, DM1000 LED, DM3000 and 2 more | 2017 | 7 |
| Microscope, Inverted Stage, Tissue Culture | Class 1 | DMi1 | 2017 | 7 |
| Microtome, Cryostat | Class 1 | CM1860UV, CM1100, CM1520, CM1950, CM1860, CM3050 S | 2017 | 8 |
| Microtome, Rotary | Class 1 | RM2245, RM2255, RM2265, RM2235, RM2125 RTS, HistoCore NANOCUT and 3 more | 2017 | 6 |
| Microtome, Sliding | Class 1 | SM2010 R | 2017 | 2 |
| Processor, Tissue, Automated | Class 1 | Peloris, HistoCore PEARL, TP1020, ASP6025, ASP200S, Leica PELORIS II and 5 more | 2017 | 5 |
| Slide Stainer, Automated | Class 1 | ST4020, Leica BOND-MAX, HistoCore SPECTRA ST, Leica BOND-III, ST5020, ST5010 (Autostainer XL) and 6 more | 2017 | 14 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Confocal microscopes, Industrial microscopes, Surgical microscopes, Sample preparation equipment, Microscope software |
|---|---|
| Certifications | Medical device registration |
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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