Tissue-Tek® Accu-Edge®
Heavy Duty Blade System
41manufacturers in China registered for this device type
2catalogue 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 | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | GES |
| Device type | Blade, Scalpel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-31 |
| Record revised | 2020-08-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4687 | In distribution | |
| 4683 | 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 |
| DeRoyal | Deroyal Industries, Inc. | 38 |
| 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 |
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.