DeRoyal
SM65A Fine Surgical BladesStainless Steel
41manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (7), Shanghai (5). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Ningbo Medsun Medical Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Suzhou Kyuan Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
Showing 12 of 41. All 41 manufacturers in China registered for Blade, Scalpel
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | GES |
| Device type | Blade, Scalpel |
| 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 | 2021-07-09 |
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 200, box of 100, case of 100, box of 10, box of 25, case of 40 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D5901 | In distribution | |
| D6206 | In distribution | |
| D6321 | In distribution | |
| D6311 | In distribution | |
| D6061 | In distribution | |
| D6211 | In distribution | |
| D5905 | In distribution | |
| D6219 | In distribution | |
| D6203 | In distribution | |
| D5907 | In distribution | |
| D6204 | In distribution | |
| D6218 | In distribution | |
| D6302 | In distribution | |
| D6207 | In distribution | |
| D6301 | In distribution | |
| D6306 | In distribution | |
| D6304 | In distribution | |
| D6503 | In distribution | |
| D6507 | In distribution | |
| D6205 | In distribution | |
| D6308 | In distribution | |
| D5906 | In distribution | |
| D6210 | In distribution | |
| D6392 | In distribution | |
| D5904 | In distribution | |
| D6303 | In distribution | |
| D6054 | In distribution | |
| D6208 | In distribution | |
| D6318 | In distribution | |
| D6305 | In distribution | |
| D6501 | In distribution | |
| D6307 | In distribution | |
| D6062 | In distribution | |
| D6201 | In distribution | |
| D4510NS | In distribution | |
| D4515NS | In distribution | |
| D6209 | In distribution | |
| D6505 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroAire® | Microaire Surgical Instruments LLC | 363 |
| Swann Morton Ltd. | Swann Morton, Ltd. | 228 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 83 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 64 |
| Kiato Plus | Aditya Dispomed Products Private Ltd. | 48 |
| Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel) | Huaiyin Medical Instruments Co., Ltd. | 42 |
| Beaver® | Beaver-Visitec International, Ltd | 40 |
| Glass VAN | HMD Healthcare India Pvt. Ltd. | 39 |
| Micro Feather Microsurgical Blade for fine incision | Feather Safety Razor Co., Ltd. | 37 |
| Techno CUT | HMD Healthcare India Pvt. Ltd. | 35 |
| Medline | Medline Industries, Inc. | 32 |
| JMU | JMU Dental, Inc | 31 |
Showing 12 of 231. All products under Blade, Scalpel
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.