DeRoyal
St. Shoulder Suspension Kit
20manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (5), Zhejiang (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 |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Cixi Cijia Handicraft Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 7 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Hengshui Runde Medical Instruments Co., Ltd. | Hengshui | Hebei | Manufacturer | 25 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
Showing 12 of 20. All 20 manufacturers in China registered for Joint, Shoulder, External Limb Component
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IQQ |
| Device type | Joint, Shoulder, External Limb Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 100, case of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-526NS | In distribution | |
| 32-1796 | In distribution | |
| 32-1519 | In distribution | |
| 32-525 | In distribution | |
| 17-10013 | In distribution | |
| 32-529 | In distribution | |
| 32-528 | In distribution | |
| 32-847 | In distribution | |
| 32-526 | In distribution | |
| 32-1746 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tehlin | TEH LIN Prosthetic & Orthopaedic, Inc. | 35 |
| Axis | College Park Industries | 20 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 5 |
| Trend | Orthofix US LLC | 4 |
| ManaMed | Manamed LLC | 4 |
| Copperfit | Ideavillage Products Corp. | 2 |
| ManaEZ Shoulder Ice CureTech | Manamed LLC | 1 |
| CoreTech | Vive Health LLC | 1 |
| Fullerton Manufacturing Limited | Fullerton Manufacturing Limited | 1 |
| Unite Medical® | Unite Medical, 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.