Penlight

Pupil Gauge Disposable Penlight

Registry build 21.09.26
53manufacturers in China registered for this device type
58catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (22), Jiangsu (14), Guangdong (7). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KYT
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Hangzhou Aosi Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 18
Wenzhou Kangju Medical Instrument Co., Ltd. Wenzhou Zhejiang Contract manufacturer 15
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Ningbo Tianbo First AID Product Co., Ltd. Ningbo Zhejiang Repacker / relabeller 66
AID United International Co., Limited Shanghai Shanghai Specification developer 65
Dongguan City Ruimi Gift Products Co Ltd Dongguan Guangdong Repacker / relabeller 62

Showing 12 of 53. All 53 manufacturers in China registered for Light, Examination, Medical, Battery Powered

Record

Regulatory record for Penlight
Listed by Rashman Corp., United States
FDA product code KYT
Device type Light, Examination, Medical, Battery Powered
Device class Class 1
Regulation 21 CFR 880.6350
Premarket notification Exempt
Record published 2022-12-05
Record revised 2023-05-03 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Labelled latex-free

Catalogue Numbers

Catalogue numbers for Penlight
Catalogue number Size Status
222-BLK In distribution
200-WHT In distribution
200-PUR In distribution
S214-PUR In distribution
S210-PUR In distribution
214-RSE In distribution
S210-BLK In distribution
214-HPK In distribution
S229 In distribution
S214-SIL In distribution
S210-HPK In distribution
200-BLK In distribution
S214-RSE In distribution
214-ROY In distribution
214-TEW In distribution
S200-CBL In distribution
210-HPK In distribution
210-BLK In distribution
200-NAV In distribution
S210-NAV In distribution
210-RED In distribution
S214-HPK In distribution
S260-WHT In distribution
200-BUR In distribution
S210-TEW In distribution
S214-AQS In distribution
S200-BLK In distribution
260-WHT In distribution
260-BLK In distribution
222-SIL In distribution
S260-BLK In distribution
S200-WHT In distribution
210-NAV In distribution
S210-GRY In distribution
S214-WHT In distribution
S200-HPK In distribution
214-BLK In distribution
S214-BLK In distribution
214-AQS In distribution
S210-RED In distribution
210-TEW In distribution
S222-BLK In distribution
S200-BUR In distribution
210-PUR In distribution
200-CBL In distribution
214-WHT In distribution
S200-NAV In distribution
S214-RED In distribution
214-PUR In distribution
S214-ROY In distribution
214-RED In distribution
210-GRY In distribution
S200-PUR In distribution
S222-SIL In distribution
S214-TEW In distribution
S210 In distribution
200-HPK In distribution
214-SIL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Adlite™ Plus American Diagnostic Corp. 20
Metalite™ American Diagnostic Corp. 11
MoleScope II Metaoptima Technology Inc. 10
Metalite™ II American Diagnostic Corp. 10
Firefly Firefly Global 9
SurgiTel Surgitel 7
PeriOptix DEN-MAT Holdings, LLC 6
Dr. Vampa Dr Vampa S.R.L. 5
Adlite™ II American Diagnostic Corp. 5
Emsrun Wuxi Emsrun Technology Co., Ltd. 4
MDF® MDF Instruments Medifriend Inc. 4
Portaled Ecleris SRL 4

Showing 12 of 309. All products under Light, Examination, Medical, Battery Powered

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