DeRoyal
Stockinette Bias Cut Cttn Bxd 6 IN x 50 YDS
24manufacturers in China registered for this device type
133catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (10), Guangdong (5), Hebei (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Dongguan Sava Sporting Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Zhejiang Qiangnao Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 2 |
| Shaoxing Annor Textile Company Limited | Shaoxing | Zhejiang | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
Showing 12 of 24. All 24 manufacturers in China registered for Cover, Limb
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IPM |
| Device type | Cover, Limb |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-09 |
| Record revised | 2024-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 40, case of 25, case of 10, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9978-09NS | In distribution | ||
| 9409-54 | In distribution | ||
| 9988-60TJ | In distribution | ||
| RB6-3 | In distribution | ||
| 9506-60NS | In distribution | ||
| 5264Q-T | In distribution | ||
| 32-1837 | In distribution | ||
| 9818-54NS | In distribution | ||
| 9508-60 | In distribution | ||
| 9706-48NS | In distribution | ||
| 9508-48 | In distribution | ||
| 9506-36 | In distribution | ||
| 9844-43 | 4 | In distribution | |
| 9604-36 | In distribution | ||
| 5266Q-T | In distribution | ||
| 9608-72 | In distribution | ||
| 9604-48 | In distribution | ||
| 32-617 | In distribution | ||
| 5244Q-T | In distribution | ||
| 9506-60 | In distribution | ||
| 9978-16NS | In distribution | ||
| RB6 | In distribution | ||
| M3022-L | In distribution | ||
| 9608-72NS | In distribution | ||
| QM-9570 | In distribution | ||
| 9978-06 | In distribution | ||
| 9608-48NS | In distribution | ||
| 9606-48NS | In distribution | ||
| RB5-3 | In distribution | ||
| 9409-54NS | In distribution | ||
| 9408-38NS | In distribution | ||
| 9800-43 | In distribution | ||
| ES1000-30 | In distribution | ||
| 9800-24 | In distribution | ||
| 9816-54 | In distribution | ||
| 9800-35 | In distribution | ||
| 9604-36NS | In distribution | ||
| 5242Q | In distribution | ||
| 9811-00 | In distribution | ||
| 9508-72 | In distribution | ||
| 9608-60 | In distribution | ||
| 9416-54NS | In distribution | ||
| 9978-12 | In distribution | ||
| RB4-5 | In distribution | ||
| 9800-34 | In distribution | ||
| 9412-54NS | In distribution | ||
| 31-657 | In distribution | ||
| 9804-56 | In distribution | ||
| 9704-48NS | In distribution | ||
| 9606-72NS | In distribution | ||
| 9504-48NS | In distribution | ||
| 32-1927 | In distribution | ||
| 9504-36 | In distribution | ||
| 9504-48 | In distribution | ||
| 9816-36NS | In distribution | ||
| 9602-36 | In distribution | ||
| 31-658 | In distribution | ||
| 9508-48NS | In distribution | ||
| 9608-48 | In distribution | ||
| 9833-63 | 4 | In distribution | |
| 9978-16 | In distribution | ||
| 9603-36 | In distribution | ||
| 9704-36 | In distribution | ||
| 9977-09NS | In distribution | ||
| 32-1617 | In distribution | ||
| 9866-54 | In distribution | ||
| 9606-54NS | In distribution | ||
| 9606-60NS | In distribution | ||
| 9800-33 | In distribution | ||
| RB3 | In distribution | ||
| RB4-3 | In distribution | ||
| 9604-48NS | In distribution | ||
| 9606-54 | In distribution | ||
| 9800-63 | In distribution | ||
| 9510-60 | In distribution | ||
| 9800-66 | In distribution | ||
| 9503-36NS | In distribution | ||
| 9800-65 | In distribution | ||
| 9706-60 | In distribution | ||
| ES1000-50 | In distribution | ||
| 9816-36 | In distribution | ||
| 9503-54 | In distribution | ||
| 9606-72 | In distribution | ||
| 9800-64 | In distribution | ||
| 9606-60 | In distribution | ||
| 9706-48 | In distribution | ||
| 9706-72 | In distribution | ||
| 9800-44 | In distribution | ||
| 9706-60NS | In distribution | ||
| 9800-46 | In distribution | ||
| 9978-12NS | In distribution | ||
| 9510-48 | In distribution | ||
| 9800-85 | In distribution | ||
| 9608-60NS | In distribution | ||
| 9502-36 | In distribution | ||
| 9816-54NS | In distribution | ||
| 9704-48 | In distribution | ||
| 9999-28NS | In distribution | ||
| 9708-72 | In distribution | ||
| 9800-84 | In distribution | ||
| RB2 | In distribution | ||
| 31-504 | In distribution | ||
| 9818-54 | In distribution | ||
| RB6-5 | In distribution | ||
| 9800-45 | In distribution | ||
| RB4 | In distribution | ||
| 9604-60NS | In distribution | ||
| 9604-60 | In distribution | ||
| 32-1886 | In distribution | ||
| 32-1056 | In distribution | ||
| 9416-54 | In distribution | ||
| 9408-38 | In distribution | ||
| 9504-36NS | In distribution | ||
| 9506-48NS | In distribution | ||
| 9504-60 | In distribution | ||
| 31-726 | In distribution | ||
| 9866-63 | 4 | In distribution | |
| 31-725 | In distribution | ||
| 9503-36 | In distribution | ||
| 9610-48 | In distribution | ||
| 9977-09 | In distribution | ||
| 9506-48 | In distribution | ||
| 9706-72NS | In distribution | ||
| 9999-28 | In distribution | ||
| 9978-09 | In distribution | ||
| 32-568 | In distribution | ||
| 9708-60 | In distribution | ||
| M3022 | In distribution | ||
| 9412-54 | In distribution | ||
| 9704-36NS | In distribution | ||
| 9606-48 | In distribution | ||
| 9800-25 | In distribution | ||
| 9506-72 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 360 |
| Juzo Dynamic | Julius Zorn, Inc. | 238 |
| Coolmax Sock | Alps South LLC | 180 |
| Tex-Care Medical | Flynt Amtex, Inc. | 128 |
| Coolblue Sock | Alps South LLC | 101 |
| Juzo Dynamic Xtra | Julius Zorn, Inc. | 90 |
| Juzo Dynamic Silver | Julius Zorn, Inc. | 90 |
| Genesee | College Park Industries | 89 |
| Sterling | College Park Industries | 77 |
| Silicone Glove | Hugh Steeper Ltd | 50 |
| PVC Glove | Hugh Steeper Ltd | 36 |
| Juzo Custom Compression Garments | Julius Zorn, Inc. | 32 |
Showing 12 of 173. All products under Cover, Limb
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.