Cover, Base
Catalogue number 5324-13, listed by Mizuho Orthopedic Systems, Inc., United States, under Bedding, Disposable, Medical. 308 manufacturers in China are registered for this product code.
308manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (73), Zhejiang (56), Hubei (49). 65 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
Showing 12 of 308. All 308 manufacturers in China registered for Bedding, Disposable, Medical
Record
| Listed by | Mizuho Orthopedic Systems, Inc., United States |
|---|---|
| FDA product code | KME |
| Device type | Bedding, Disposable, Medical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6060 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-08-05 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5324-13 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wings | Cardinal Health | 38 |
| Curaplex | Bound Tree Medical, LLC | 37 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 34 |
| PremierPro | Prestige Ameritech | 22 |
| Allen | Hill-ROM, Inc. | 20 |
| AllCare | Allcare, Inc. | 18 |
| Cardinal Health | Cardinal Health 200, LLC | 18 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 17 |
| Thermoflect | Encompass Group, L.L.C. | 17 |
| Action® | Action Products, Inc. | 15 |
| Novaplus | Cardinal Health | 14 |
| Primo/ASP Medical | ASP Global, LLC | 13 |
Showing 12 of 228. All products under Bedding, Disposable, Medical
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.