TO BE Assigned

91 catalogue numbers from DL4097/276.FWG, listed by FGX International Inc., under Spectacle, Magnifying. 360 manufacturers in China are registered for this product code.

Registry build 21.09.26
360manufacturers in China registered for this device type
91catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (198), Guangdong (59), Jiangsu (31). 37 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HOI
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Wenzhou Kangcheng Eyewear Co., Ltd. Wenzhou Zhejiang Contract manufacturer 6
Wenzhou Summer International Limited Wenzhou Zhejiang Contract manufacturer 6
Wenzhou Sunmax International Trade Co., Ltd. Wenzhou Zhejiang Contract manufacturer 6
Xiamen Tanuo Optical Technology Co., Ltd. Xiamen Fujian Contract manufacturer 6
Jiangsu Yuchang Optical Glasses Co., Ltd. Danyang Jiangsu Contract manufacturer 5
Wenzhou Kangjing Optics Co., Ltd. Wenzhou Zhejiang Contract manufacturer 5
Wenzhou Mingshida Light Industrial Products Co., Ltd. Wenzhou Zhejiang Contract manufacturer 5
Wenzhou Rainbow Optical Co., Ltd. Wenzhou Zhejiang Contract manufacturer 5
Wenzhou Young Giant Trade Co., Ltd. Wenzhou Zhejiang Contract manufacturer 5
Wenzhou Zengtai Industry AND Trade Co., Ltd. Wenzhou Zhejiang Contract manufacturer 5
Zhejiang Yinfeng Glasses Co., Ltd. Linhai, Taizhou Zhejiang Contract manufacturer 5

Showing 12 of 360. All 360 manufacturers in China registered for Spectacle, Magnifying

Record

Regulatory record for TO BE Assigned
Listed by FGX International Inc.
FDA product code HOI
Device type Spectacle, Magnifying
Device class Class 1
Regulation 21 CFR 886.5840
Premarket notification Exempt
Record published 2022-06-22
Record revised 2023-12-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Distribution end date 2023-12-20

Catalogue Numbers

Catalogue numbers for TO BE Assigned
Catalogue number Size Status
DL4097/276.FWG In distribution
DL4094/211.FWG In distribution
5012252-000.APC In distribution
DL4014/100.MWM In distribution
5010074-350.APC In distribution
5010071-100.APC In distribution
5010016-350.APC In distribution
5012250-000.APC In distribution
5010074-200.APC In distribution
5010072-100.APC In distribution
GWFC-RDR.LRI In distribution
5013887-100.INT In distribution
RSB125.LRI In distribution
5012241-000.APC In distribution
5010073-100.APC In distribution
5010072-350.APC In distribution
GWNF-RDR.LRI In distribution
5012249-000.APC In distribution
5012247-000.APC In distribution
5013887-200.INT In distribution
DL4013/330.MWM In distribution
ARD302-175.MCV In distribution
5010071-250.APC In distribution
5010072-250.APC In distribution
5010073-250.APC In distribution
5013887-250.INT In distribution
5012244-000.APC In distribution
DL4093/351.FWG In distribution
DL4012/471.MWM In distribution
LEVEL4-175W.LRI In distribution
5010076-150.APC In distribution
5010071-200.APC In distribution
RSB150.LRI In distribution
5010307-350.APC In distribution
DL4010/579.MWM In distribution
DL4082/37.MWM In distribution
GWILL-RDR.LRI In distribution
5012245-000.APC In distribution
RD-MULTI-WK.RTN In distribution
5010072-150.APC In distribution
5012240-000.APC In distribution
5010273-350.APC In distribution
5012242-000.APC In distribution
5012251-000.APC In distribution
5010073-200.APC In distribution
5010074-250.APC In distribution
5013887-350.INT In distribution
5012243-000.APC In distribution
5010073-350.APC In distribution
GWNF-RDR.LRI In distribution
ASTACC33.CTS In distribution
ARD302-150.MCV In distribution
ARD302-250.MCV In distribution
5010014-350.APC In distribution
5010074-300.APC In distribution
5010076-250.APC In distribution
5010076-350.APC In distribution
5013887-300.INT In distribution
GWMV-RDR.LRI In distribution
GWRDR-RAP.LRI In distribution
5010073-150.APC In distribution
5010072-300.APC In distribution
ARD302-125.MCV In distribution
5010074-100.APC In distribution
5010071-350.APC In distribution
BPR-225.LRI In distribution
DL4080/37.MWM In distribution
5010071-150.APC In distribution
5010076-200.APC In distribution
LEVEL4-175W.LRI In distribution
5012253-000.APC In distribution
GWRDR-RAP.LRI In distribution
5010074-150.APC In distribution
5010073-300.APC In distribution
5010013-350.APC In distribution
R7927.LRI In distribution
5010076-100.APC In distribution
5010306-350.APC In distribution
BPR-275.LRI In distribution
5012248-000.APC In distribution
5010071-300.APC In distribution
ARD302-200.MCV In distribution
GWMV-RDR.LRI In distribution
5010076-300.APC In distribution
GWFC-RDR.LRI In distribution
5013887-150.INT In distribution
5012246-000.APC In distribution
5010072-200.APC In distribution
DL4011/282.MWM In distribution
1017658-350.FDR In distribution
3865003.LTS Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Foster Grant FGX International Inc. 11,937
Readers.com FGX International Inc. 8,939
Design Optics FGX International Inc. 3,307
Unbranded FGX International Inc. 2,195
ICU Eyewear Zoom Eyeworks DBA ICU Eyewear, Inc. 2,129
Sofia Vergara FGX International Inc. 1,405
Colors in Optics Colors IN Optics Ltd. 1,078
Magnivision FGX International Inc. 714
Simply Specs FGX International Inc. 628
Ironman FGX International Inc. 499
EZ2C FGX International Inc. 499
Betsey Johnson FGX International Inc. 422

Showing 12 of 139. All products under Spectacle, Magnifying

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