RPI-Check
Reagent for instrument
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Zhejiang Changdi Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 16 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Ningbo Jenius Polymer SCI-Tech Co., Ltd. | Yinzhou District, Ningbo | Zhejiang | Manufacturer | 29 |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 28 |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou | Jiangsu | Remanufacturer | 26 |
Showing 12 of 16. All 16 manufacturers in China registered for Solution, Isotonic
Record
| Listed by | Mechatronics USA, United States |
|---|---|
| FDA product code | JCE |
| Device type | Solution, Isotonic |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-12-05 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Liquid Chemical |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A0016912 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Redipor | Analytichem USA, Inc. | 7 |
| Thermo Scientific Nerl® | Fisher Diagnostics | 4 |
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.