Surtex

Corneal Trephine Handle Ø 6.75 mm Stainless Steel

Registry build 21.09.26
2manufacturers in China registered for this device type
27catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HRH
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

Record

Regulatory record for Surtex
Listed by Surtex Instruments Ltd, United Kingdom
FDA product code HRH
Device type Trephine, Manual, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Remanufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2026-05-12

Specifications

Specifications
MRI safety MR Conditional

Catalogue Numbers

Catalogue numbers for Surtex
Catalogue number Size Status
OP-401-03 In distribution
OP-401-01 In distribution
OP-400-11 In distribution
OP-400-07 In distribution
OP-400-14 In distribution
OP-400-03 In distribution
OP-400-01 In distribution
OP-401-09 In distribution
OP-400-06 In distribution
OP-400-09 In distribution
OP-401-07 In distribution
OP-401-10 In distribution
OP-401-12 In distribution
OP-401-02 In distribution
OP-400-04 In distribution
OP-401-08 In distribution
OP-401-05 In distribution
OP-401-11 In distribution
OP-400-08 In distribution
OP-400-05 In distribution
OP-400-12 In distribution
OP-401-06 In distribution
OP-401-04 In distribution
OP-400-13 In distribution
OP-400-02 In distribution
OP-400-10 In distribution
OP-401-13 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Coronet Network Medical Products, Ltd. 203
Ambler Surgical Ambler Surgical, LLC 106
Surgistar Surgistar, Inc. 94
Corneal Trephine Katena Products, Inc. 72
MSI Precision Specialty Instruments MED Saver, Inc. 53
Bausch + Lomb Bausch & Lomb Incorporated 50
Coronet CorneaGen 44
Novo Surgical Novo Surgical, Inc. 30
Eyetec Network Medical Products, Ltd. 28
Beaver Beaver-Visitec International, Ltd 26
Corneal Trephine Blade Sontec Instruments, Inc. 25
V. Mueller Carefusion 2200, Inc. 24

Showing 12 of 98. All products under Trephine, Manual, 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