Topfine Insulin Syringe

Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after…

Registry build 21.09.26

Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 mI/cc, 0.5 mI/cc and 1 mi/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.

60manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMF
Manufacturer City Province Registered as Device types
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Zhejiang Runqiang Medical Instruments Co., Ltd. Jiaxing Zhejiang Contract manufacturer 9
Wuxi Yushou Medical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Shenzhen HYS Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Zhejiang INI Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 4
ShanDong WeiGao Group Medical Polymer Co., Ltd. Weihai Shandong Contract manufacturer 3
Hantech (Ningbo) Medical Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 3

Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston

Record

Regulatory record for Topfine Insulin Syringe
Listed by Medexel Co., Ltd., South Korea
FDA product code FMF
Device type Syringe, Piston
Device class Class 2
Regulation 21 CFR 880.5860
Establishment Contract manufacturer, Manufacturer
510(k) K063348
Record published 2026-04-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 1 to 30 °C
Sizes Needle gauge 28 to 31 G; length 5 to 12.7 mm

Catalogue Numbers

Catalogue numbers for Topfine Insulin Syringe
Catalogue number Size Status
30Gx5mm 0.5ml Needle Gauge 30 G In distribution
28Gx5mm 1.0ml Needle Gauge 28 G In distribution
31Gx8mm 1.0ml Needle Gauge 31 G In distribution
31Gx5mm 0.5ml Needle Gauge 31 G In distribution
31Gx8mm 0.5ml Needle Gauge 31 G In distribution
28Gx8mm 0.5ml Needle Gauge 28 G In distribution
28Gx5mm 0.5ml Needle Gauge 28 G In distribution
29Gx12.7mm 0.5ml Needle Gauge 29 G In distribution
30Gx8mm 1.0ml Needle Gauge 30 G In distribution
29Gx12.7mm 1.0ml Needle Gauge 29 G In distribution
30Gx12.7mm 0.5ml Needle Gauge 30 G In distribution
30Gx5mm 1.0ml Needle Gauge 30 G In distribution
29Gx8mm 1.0ml Needle Gauge 29 G In distribution
30Gx12.7mm 1.0ml Needle Gauge 30 G In distribution
28Gx8mm 1.0ml Needle Gauge 28 G In distribution
31Gx5mm 1.0ml Needle Gauge 31 G In distribution
28Gx12.7mm 0.5ml Needle Gauge 28 G In distribution
30Gx8mm 0.5ml Needle Gauge 30 G In distribution
31Gx12.7mm 1.0ml Needle Gauge 31 G In distribution
29Gx5mm 0.5ml Needle Gauge 29 G In distribution
28Gx12.7mm 1.0ml Needle Gauge 28 G In distribution
29Gx8mm 0.5ml Needle Gauge 29 G In distribution
31Gx12.7mm 0.5ml Needle Gauge 31 G In distribution
29Gx5mm 1.0ml Needle Gauge 29 G In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Yeso med Wuxi Yushou Medical Appliances Co., Ltd. 228
Medallion® Merit Medical Systems, Inc. 223
Merit Medical® Merit Medical Systems, Inc. 192
Monoject Cardinal Health 188
Medline Medline Industries, Inc. 127
EasyTouch MHC Medical Products 122
Medline Industries, Inc. Medline Industries, Inc. 99
Arrow Teleflex Medical LLC 94
Ceros Rhino Medical Supply Inc 92
Enteral Feeding Medela LLC 87
Monoject Cardinal Health 200, LLC 83
HSW Soft-Ject® Henke-Sass Wolf, Gmbh. 80

Showing 12 of 913. All products under Syringe, Piston

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