Auto Volume Expressor
Accessory to the BioArchive System
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (3), Anhui (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao Haier Biomedical Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 3 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Aikang Medtech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
| MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd. | Pidu District Chengdu | Sichuan | Manufacturer | 3 |
| Midea Biomedical Co., Ltd. | Hefei | Anhui | Manufacturer | 2 |
| Zhejiang Heli Refrigeration Equipment Co., Ltd. | Jinhua | Zhejiang | Manufacturer | 1 |
| Zhongke Meiling Cryogenics Company Limited. | Hefei | Anhui | Manufacturer | 1 |
Record
| Listed by | ThermoGenesis Corp., United States |
|---|---|
| FDA product code | KSE |
| Device type | Refrigerator, Freezer, Blood Storage |
| Device class | Class 2 |
| Regulation | 21 CFR 864.9700 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-04-05 |
| Record revised | 2021-01-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8-4100-0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| B Medical Systems | B Medical Systems Sarl | 104 |
| Follett | Follett Corporation | 97 |
| i.Series® | Helmer Inc. | 69 |
| Horizon Series™ | Helmer Inc. | 59 |
| Haier | Qingdao Haier Biomedical Co., Ltd. | 41 |
| Thermo Scientific | KEY Scientific Inc | 29 |
| Thermo Scientific Jewett Blood Bank Refrigerator | KEY Scientific Inc | 27 |
| Thermo Scientific ™ CryoMed™ | Thermo Fisher Scientific (Asheville) LLC | 24 |
| Biotecno | Biotecno Industria E Comercio Ltda | 23 |
| Thermo Scientific TSX Series High-Performance Plasma Freezer | KEY Scientific Inc | 20 |
| Thermo Scientific Forma Blood Bank Refrigerator | KEY Scientific Inc | 19 |
| K2 Scientific, LLC | K2 Scientific, LLC | 19 |
Showing 12 of 73. All products under Refrigerator, Freezer, Blood Storage
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.