Curaplex
*Custom* Curaplex PPE Kit with Digital Thermometer
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Hubei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiantao Zhongyi Safety & Protection Products Co., Ltd. | Xiantao | Hubei | Manufacturer | 10 |
| Wenzhou Sanshan Optics Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 8 |
| Chengde Technology Co., Ltd. | Longgang | Zhejiang | Manufacturer | 5 |
| Shenzhen Mondial Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | NZJ |
| Device type | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6260 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-15 |
| Record revised | 2023-09-13 (version 6) |
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 |
| Packaging | Case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8600-01376 | In distribution | |
| 8600-01501 | In distribution | |
| 8600-01373 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pasture F550G Respirator | Pasture Pharma PTE Ltd | 2 |
| Pasture A520G Respirator | Pasture Pharma PTE Ltd | 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.