Tissue-Tek® TEC™ 6
Cryo Module (Requires connnection to product code 5108 for operation)
7manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | IDW |
| Device type | Dispensers, Paraffin |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-06 |
| Record revised | 2022-09-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5250 | In distribution | |
| 5250 | In distribution | |
| 5785 | In distribution | |
| 5109 | In distribution | |
| 5782 | In distribution | |
| 5108 | In distribution | |
| 5110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 19 |
| Thermo Fisher | Shandon Diagnostics Limited | 12 |
| HistoPro® | Rushabh Instruments, LLC | 8 |
| Tissue-Tek AutoTEC® a120 | Sakura Finetek U.S.A., Inc. | 1 |
| FlexPath Blox | Inpeco SA | 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.