Haier
Combined Refrigerator and Freezer
5manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | Qingdao Haier Biomedical Co., Ltd., China |
|---|---|
| FDA product code | JRM |
| Device type | Freezer |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HYC-130GD | In distribution | |
| HYC-610 | In distribution | |
| HYCD-319A | In distribution | |
| HYC-639 | In distribution | |
| HYC-85GD | In distribution | |
| HYCD-469A | In distribution | |
| HYC-940 | In distribution | |
| HYC-1378 | In distribution | |
| HYC-130FD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| B Medical Systems | B Medical Systems Sarl | 104 |
| Haier Biomedical | Qingdao Haier Biomedical Co., Ltd. | 4 |
| Farrar | Helmer Inc. | 1 |
| 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.