Farrar
Ultralow temperature freezer
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Zheng HE Cross-Border Limited | Hong Kong | Hong Kong | Exporter | 6 |
| Qingdao Haier Biomedical Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 3 |
| Midea Biomedical Co., Ltd. | Hefei | Anhui | Manufacturer | 2 |
Record
| Listed by | Helmer Inc., United States |
|---|---|
| FDA product code | JRM |
| Device type | Freezer |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FCF133 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| B Medical Systems | B Medical Systems Sarl | 104 |
| Haier | Qingdao Haier Biomedical Co., Ltd. | 9 |
| Haier Biomedical | Qingdao Haier Biomedical Co., Ltd. | 4 |
| CBS Integral Freezer | Cryo BIO System | 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.