DeRoyal
Double Edge Razor Blade
34manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (12), Zhejiang (10), Jiangsu (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Yee Hing Foon Plastic Co., Ltd. / Hope Come International | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zhejiang Beauty AND Health Electrical Appliance Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 3 |
| Raymond (Panyu Nansha) Electrical Appliances Development Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 2 |
| Ningbo Kaili Holding Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
Showing 12 of 34. All 34 manufacturers in China registered for Razor, Surgical
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | LWK |
| Device type | Razor, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-30 |
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 50, case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-051 | In distribution | |
| 32-1992 | In distribution | |
| 31-297 | In distribution | |
| 31-263 | In distribution | |
| 32-488 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Juliet ® Instrumentation | Spineart SA | 29 |
| 3M™ | 3M Company | 24 |
| Solventum™ | Solventum US LLC | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 8 |
| Romeo posterior osteosynthesis system | Spineart SA | 4 |
| Razor, Surgical | Carefusion 2200, Inc. | 4 |
| Medline | Medline Industries, Inc. | 4 |
| SourceMark | Sourcemark, LLC. | 4 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Twin Blade Razors | Dynarex Corp. | 1 |
| DawnMist | Dukal LLC | 1 |
| AMSafe® Prep Razor | Amsino Medical Inc. | 1 |
Showing 12 of 23. All products under Razor, Surgical
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.