Optego

OEP Chairside Diagnostic Set +/-0.25 red handle +/-0.50 orange handle +0.50/+0.75 yellow handle +1.00/+1.25 green handle +1.50/+1.75 blue handle +/-2.00 violet handle flipper base

Registry build 21.09.26
13manufacturers in China registered for this device type
66catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (2), Beijing (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 HPC
Manufacturer City Province Registered as Device types
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Taiyuan Shaanxi Contract manufacturer 14
Update Optical Manufacturer Limited Longgang District, Shenzhen Guangdong Contract manufacturer 3
Beijing Hongdee Corporation Beijing Beijing Private-label distributor 43
Danyang NEW Hope Medical Equipment Co., Ltd. Danyang Jiangsu Manufacturer 38
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
Wuxi Zontai Int’l Corporation Ltd. Wuxi Jiangsu Contract manufacturer 22
Shanghai Link Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 21
Gino Optical (Shanghai) Co., Ltd. Shanghai Shanghai Manufacturer 15
Shanghai Canton Optics Equipment Co., Ltd. Shanghai Shanghai Manufacturer 14
Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. Nanjing Jiangsu Contract manufacturer 12
Wenzhou Hala Trade Co., Ltd. Wenzhuo Zhejiang Manufacturer 7

Showing 12 of 13. All 13 manufacturers in China registered for Set, Lens, Trial, Ophthalmic

Record

Regulatory record for Optego
Listed by Optego Vision USA, Inc., United States
FDA product code HPC
Device type Set, Lens, Trial, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.1405
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-12-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Optego
Catalogue number Size Status
93456 In distribution
94282 In distribution
94277 In distribution
94280 In distribution
94261 In distribution
94209 In distribution
94259 In distribution
93455 In distribution
94211 In distribution
94252 In distribution
94208 In distribution
93451 In distribution
94254 In distribution
94283 In distribution
94249 In distribution
94299 In distribution
94206 In distribution
94297 In distribution
94294 In distribution
94296 In distribution
94256 In distribution
94293 In distribution
94272 In distribution
94285 In distribution
94279 In distribution
94207 In distribution
94290 In distribution
94202 In distribution
94251 In distribution
94292 In distribution
94288 In distribution
94260 In distribution
94287 In distribution
93458 In distribution
94212 In distribution
94298 In distribution
94263 In distribution
94200 In distribution
94278 In distribution
94210 In distribution
94271 In distribution
94270 In distribution
94273 In distribution
94253 In distribution
94291 In distribution
94275 In distribution
94274 In distribution
94265 In distribution
94295 In distribution
94258 In distribution
94255 In distribution
94203 In distribution
93450 In distribution
94262 In distribution
94284 In distribution
94201 In distribution
94281 In distribution
94286 In distribution
94276 In distribution
94289 In distribution
93457 In distribution
94204 In distribution
94264 In distribution
94205 In distribution
94250 In distribution
94257 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bernell Bernell 175
Fresnel Prism AND Lens Fresnel Prism & Lens Co. 32
Tiannuo / Tnmed Lianyungang Tiannuo Optical Instrument Co., Ltd. 9
Rexxam Rexxam.co., Ltd. 2
BK S2, wooden case with handle Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
BK 2, coated, wooden case with handle Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
BK S1/T without convex cylinders, coated table version, trial lens case Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
BK 2, without convex cylinders, wooden case with handle Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
BK S3, wooden lens case with handle Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
Prism Lens Case, coated Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1
BK S1/T without convex cylinders, table version, trial lens case Oculus Optikgeräte Gesellschaft mit beschränkter Haftung 1

Showing 12 of 39. All products under Set, Lens, Trial, 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