Epsilon USA

Lieberman Eye Speculum "K" Wire Screw Type Flat Arms Temporal Bend (88mm Overall) Stainless Steel

Registry build 21.09.26
11manufacturers in China registered for this device type
35catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HNC
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Ophsurin Co., Ltd. Suqian Jiangsu Contract manufacturer 6
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

Record

Regulatory record for Epsilon USA
Listed by Epsilon EYE Care PVT., Ltd., India
FDA product code HNC
Device type Specula, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-12-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization, Moist Heat or Steam Sterilization, Ethylene Oxide
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Epsilon USA
Catalogue number Size Status
E1-59 In distribution
E1-OR016 In distribution
E1-45K In distribution
E1-271 In distribution
E1-253R In distribution
E1-265 In distribution
E1-46B In distribution
E1-149 In distribution
E1-205 In distribution
E1-254R In distribution
E1-201 In distribution
E1-48 In distribution
E1-254L In distribution
E1-149SB In distribution
E1-126 In distribution
E1-253L In distribution
E1-95C In distribution
E1-46C In distribution
E1-203 In distribution
E1-221 In distribution
E1-125 In distribution
E1-95 In distribution
E1-93 In distribution
E1-215 In distribution
E1-9 In distribution
E1-202 In distribution
E1-46 In distribution
E1-207 In distribution
E1-206 In distribution
E1-23 In distribution
E1-219 In distribution
E1-95B In distribution
E1-210 In distribution
E1-156 In distribution
E1-144 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MSI Precision Specialty Instruments MED Saver, Inc. 214
Ambler Surgical Ambler Surgical, LLC 169
Sklar Sklar Corporation 121
Walcott Rx Products Walcott Rx Product Inc 115
Ophthalmic Speculum Aurora Surgical, LLC 93
MR Phaco Crestpoint Management Ltd. 84
Millennium Avalign Technologies, Inc. 79
Ophthalmic Speculum Katena Products, Inc. 76
Stephens Instruments Krishna Imports Inc 61
Bausch + Lomb Bausch & Lomb Incorporated 55
Surtex Surtex Instruments Ltd 54
Rumex Rumex International Co. 47

Showing 12 of 360. All products under Specula, 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