DeRoyal
Abdominal Binder, Ilio Bypass
20manufacturers in China registered for this device type
106catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (4), Shanghai (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Yishun Medical Equipment Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 10 |
| Shenzhen Caremed Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Guangzhou Yifangjia Textile And Garment Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 5 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
| Dongguan Park Sport Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 20 |
| Taicang Yigao Medical Technology Co., Ltd. | Taicang | Jiangsu | Manufacturer | 20 |
Showing 12 of 20. All 20 manufacturers in China registered for Binder, Abdominal
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FSD |
| Device type | Binder, Abdominal |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24, case of 12, case of 32, case of 36, case of 20, case of 27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13530009 | In distribution | |
| 13542005 | In distribution | |
| 13871000 | In distribution | |
| 13760406 | In distribution | |
| 13590000 | In distribution | |
| 13530005 | In distribution | |
| 13780400 | In distribution | |
| 13530007 | In distribution | |
| 13650900 | In distribution | |
| 145T20 | In distribution | |
| 13790309 | In distribution | |
| 13653008 | In distribution | |
| 13970000 | In distribution | |
| 1144PP | In distribution | |
| 505P10 | In distribution | |
| 145T10 | In distribution | |
| 13995000 | In distribution | |
| A132056 | In distribution | |
| M5001-XL | In distribution | |
| 13790405 | In distribution | |
| 13749300 | In distribution | |
| 13654009 | In distribution | |
| 13983000 | In distribution | |
| 13991000 | In distribution | |
| A132067 | In distribution | |
| 20-1221A-00 | In distribution | |
| 13530006 | In distribution | |
| M5001-M | In distribution | |
| 13780300 | In distribution | |
| 13550008 | In distribution | |
| 13542008 | In distribution | |
| 13760300 | In distribution | |
| 13790307 | In distribution | |
| 1141PP | In distribution | |
| 13541008 | In distribution | |
| 13982000 | In distribution | |
| 13655010 | In distribution | |
| 13992000 | In distribution | |
| 13652067 | In distribution | |
| 134T20 | In distribution | |
| 13872900 | In distribution | |
| 13651056 | In distribution | |
| 13650000 | In distribution | |
| A131067 | In distribution | |
| 13541007 | In distribution | |
| 13550005 | In distribution | |
| 13790305 | In distribution | |
| 1142PP | In distribution | |
| 13530000 | In distribution | |
| M5001-XXL | In distribution | |
| 13640000 | In distribution | |
| 1145PP | In distribution | |
| 13760307 | In distribution | |
| 506P10 | In distribution | |
| 1146PP | In distribution | |
| 13530008 | In distribution | |
| A133000 | In distribution | |
| 1143PP | In distribution | |
| 504P10 | In distribution | |
| 13740400 | In distribution | |
| 13550006 | In distribution | |
| 13960000 | In distribution | |
| 13760309 | In distribution | |
| 13760408 | In distribution | |
| 13760306 | In distribution | |
| 13760400 | In distribution | |
| 13550007 | In distribution | |
| 13640000-B | In distribution | |
| 13662067 | In distribution | |
| 13790306 | In distribution | |
| 13660000 | In distribution | |
| 20-1225A-00 | In distribution | |
| 13790409 | In distribution | |
| 13663008 | In distribution | |
| M5001-L | In distribution | |
| 13981000 | In distribution | |
| 13740300 | In distribution | |
| 13984000 | In distribution | |
| 13664009 | In distribution | |
| 13749400 | In distribution | |
| 13760407 | In distribution | |
| 13950000 | In distribution | |
| 100T30 | In distribution | |
| 13790308 | In distribution | |
| 1140PP | In distribution | |
| M5001-XXXL | In distribution | |
| 13790408 | In distribution | |
| 20-1228A-00 | In distribution | |
| 13542007 | In distribution | |
| 13665010 | In distribution | |
| 507P10 | In distribution | |
| A131056 | In distribution | |
| 13661056 | In distribution | |
| 13600000 | In distribution | |
| M5001-S | In distribution | |
| 13630000 | In distribution | |
| 508P10 | In distribution | |
| 13993000 | In distribution | |
| 13994000 | In distribution | |
| 13790407 | In distribution | |
| 13790406 | In distribution | |
| 134T10 | In distribution | |
| 503P10 | In distribution | |
| 13541006 | In distribution | |
| 13985000 | In distribution | |
| 13760308 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Binder, Abdominal | Tetra Medical Supply Corp. | 55 |
| Kendall | Cardinal Health | 28 |
| Momcozy | Shenzhen Root Innovation Technology Co., Ltd. | 24 |
| Dale Abdominal Binder | Dale Medical Products, Inc. | 18 |
| E.M Adams Co., Inc. | E.M. Adams Co., Inc. | 16 |
| Abdominal Binder | Dynarex Corp. | 10 |
| Ab Binder | Pepper Medical, Inc. | 7 |
| Procare | DJO, LLC | 7 |
| M-Brace Air | Indaco SRL | 6 |
| Primo | ASP Global, LLC | 6 |
| Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 6 |
| ASP Medical | ASP Global, LLC | 6 |
Showing 12 of 121. All products under Binder, Abdominal
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.