Thermo Fisher
220-240V 50/60 Hz (CHINA ONLY)
7manufacturers in China registered for this device type
12catalogue 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 | Shandon Diagnostics Limited, United Kingdom |
|---|---|
| FDA product code | IDW |
| Device type | Dispensers, Paraffin |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-16 |
| Record revised | 2023-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-11-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Histostar Ex-Demo | In distribution | |
| Histostar Cold Module | In distribution | |
| Histostar | In distribution | |
| EMBEDDING MODULE | In distribution | |
| Cold Module | In distribution | |
| HISTOSTAR 100-120V | In distribution | |
| Histostar | In distribution | |
| EMBEDDING MODULE | In distribution | |
| Cold Module | In distribution | |
| COLD MODULE | In distribution | |
| HISTOSTAR | In distribution | |
| Histostar | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 19 |
| HistoPro® | Rushabh Instruments, LLC | 8 |
| Tissue-Tek® TEC™ 6 | Sakura Finetek U.S.A., Inc. | 7 |
| 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.