MakEdge

Clear Cornea Knife 2.75MM Angled Single Bevel

Registry build 21.09.26
12manufacturers in China registered for this device type
58catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code HNN
Manufacturer City Province Registered as Device types
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
66 Vision Tech Co., Ltd. Suzhou Jiangsu Private-label distributor 24
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20
Sihong Ophsurin Co., Ltd. Suqian Jiangsu Manufacturer 17
Huaian Frimen Co., Ltd. Huaian Jiangsu Manufacturer 16
Huaian Wolfram Surgical Instruments Huaian Jiangsu Manufacturer 14
2nd Sight Medical Co., Ltd. Changzhou Jiangsu Manufacturer 1
Shaanxi Xingmao Industry Co., Ltd. Xi An Shaanxi Private-label distributor 1

Record

Regulatory record for MakEdge
Listed by Makvin Surgical LLC, United States
FDA product code HNN
Device type Knife, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Repacker / relabeller, Complaint-file establishment
Premarket notification Exempt
Record published 2025-12-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for MakEdge
Catalogue number Size Status
1727300 In distribution
1418220 In distribution
1428280 In distribution
1827190 In distribution
1618200 In distribution
1617200 In distribution
1617260 In distribution
1528300 In distribution
1418300 In distribution
1518240 In distribution
1518275 In distribution
1428300 In distribution
1727450 In distribution
1418260 In distribution
1418265 In distribution
1528275 In distribution
1518250 In distribution
1827200 In distribution
1418180 In distribution
1428200 In distribution
1418275 In distribution
1727150 In distribution
1518265 In distribution
1725150 In distribution
1528240 In distribution
1418280 In distribution
1418120 In distribution
1828230 In distribution
1724150 In distribution
1418240 In distribution
1428260 In distribution
1518280 In distribution
1827250 In distribution
1528220 In distribution
1528250 In distribution
1828200 In distribution
1827210 In distribution
1828210 In distribution
1618250 In distribution
1428250 In distribution
1828250 In distribution
1428285 In distribution
1418320 In distribution
1428275 In distribution
1528265 In distribution
1418250 In distribution
1618220 In distribution
1518220 In distribution
1727225 In distribution
1618260 In distribution
1528280 In distribution
1418200 In distribution
1428220 In distribution
1827230 In distribution
1428240 In distribution
1828190 In distribution
1428320 In distribution
1518300 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 283
Mani Ophthalmic Knife Mani, Inc. 234
Unique Edge Unique Technologies, Inc. 186
Sharpoint Surgical Specialties México, S. de R.L. de C.V. 162
MSI Precision Specialty Instruments MED Saver, Inc. 154
Mastel Precision Surgical Instruments, Inc. Mastel Surgical Inc. 146
Anodyne Surgical Psi/Eye-Ko, Inc. 115
Ophthalmic Knife Ovation International 81
Ophthalmic Knife Katena Products, Inc. 72
Premier Edge® Microsurgical Knives Oasis Medical, Inc. 69
Micro Feather Disposable Ophthalmic Scalpel with plastic handle Feather Safety Razor Co., Ltd. 63
ExactEtch Diamatrix 63

Showing 12 of 434. All products under Knife, Ophthalmic

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer