PC
Clinical Refractometer
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (2), Guangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Record
| Listed by | Allied Medical LLC, United States |
|---|---|
| FDA product code | JRE |
| Device type | Refractometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-08 |
| Record revised | 2025-10-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S2020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics | Teco Diagnostics | 5 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 2 |
| Accustrip 10-Parameter Urine Reagent Strip | Jant Pharmacal Corp. | 1 |
| Accustrip URS Strips + Reader | Jant Pharmacal Corp. | 1 |
| Urine Reagent Strips, 10-parameter | LW Scientific, Inc. | 1 |
| Reichert® Digital USG-Chek | Reichert Inc. | 1 |
| Detector UA 10 | Immunostics, Inc. | 1 |
| Clinical Refractometers Reichert® Digital Clinic-Chek | Reichert Inc. | 1 |
| Multistix® 9 Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Accutest | Jant Pharmacal Corp. | 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.