Tissue-Tek® Cryo3®
Specimen Holders, Medium
8manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | IDP |
| Device type | Microtome, Cryostat |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-20 |
| Record revised | 2020-12-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6202 | In distribution | |
| 5807 | In distribution | |
| 6200 | In distribution | |
| 5808 | In distribution | |
| 5809 | In distribution | |
| 6201 | In distribution | |
| 6209 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 76 |
| CT520 Cryostat Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| 6250 Cryostat Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| CT620 Cryostat Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 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.