Curaplex
Curaplex Temp and O2 Temp Kit
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Jinhua Ivy Home Textile Co., Limited | Jinhua | Zhejiang | Contract manufacturer | 18 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Shenzhen Changkun Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Guangdong Prestige Technology Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 4 |
| Shenzhen Zhongde Audio-Technical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | PXH |
| Device type | Thermometer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 670208-KIT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Northside Hospital | ASP Global, LLC | 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.