Clarapath™ SectionStar™
Automated tissue sectioning and transfer system, V2
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Clarapath, Inc., United States |
|---|---|
| FDA product code | IDO |
| Device type | Microtome, Rotary |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 810-00001 | In distribution | |
| 810-00002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 20 |
| Accu-Cut® SRM™ 200 | Sakura Finetek U.S.A., Inc. | 5 |
| Tissue-Tek® | Sakura Finetek U.S.A., Inc. | 2 |
| Accu-Cut® SRM™ 300 LT | Sakura Finetek U.S.A., Inc. | 2 |
| SectionStar | Clarapath, Inc. | 1 |
| 2065A Auto Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| LS-2065 Rotary Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| MT1 Rotary Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| Tissue-Tek AutoSection® | Sakura Finetek U.S.A., Inc. | 1 |
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.