Epsilon USA

Desmarres Lid Retractor 15 mm Stainless Steel

Registry build 21.09.26
8manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HNI
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
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
Suzhou Virgil Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 20
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 HNI
Device type Retractor, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-06-26

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
EC-1-15 In distribution
EC-1-13 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 70
MSI Precision Specialty Instruments MED Saver, Inc. 59
Ambler Surgical Ambler Surgical, LLC 55
Duckworth & Kent Duckworth AND Kent Limited 54
V. Mueller Steris Corporation 43
Sklar® Sklar Corporation 28
Retractor KLS-Martin L.P. 27
Desmarres LID Retractor Sontec Instruments, Inc. 26
Bausch + Lomb Bausch & Lomb Incorporated 26
Pilling Teleflex Medical LLC 25
Aesculap Aesculap AG 24
Stephens Instruments Krishna Imports Inc 21

Showing 12 of 120. All products under Retractor, 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