Micro-Mate®

Interchangeable 10mL in 1/5mL, Glass Tip

Registry build 21.09.26
60manufacturers in China registered for this device type
23catalogue numbers in this listing
1recall

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 Micro-Mate®
Listed by Cadence Science, Inc., United States
FDA product code FMF
Device type Syringe, Piston
Device class Class 2
Regulation 21 CFR 880.5860
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2016-09-20
Record revised 2020-02-27 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 12
Distribution end date 2019-11-30

Catalogue Numbers

Catalogue numbers for Micro-Mate®
Catalogue number Size Status
5029 Withdrawn
5209 Withdrawn
5028 Withdrawn
5049 Withdrawn
5008 Withdrawn
5057 Withdrawn
5009 Withdrawn
5047 Withdrawn
5019 Withdrawn
5208 Withdrawn
5037 Withdrawn
5027 Withdrawn
5059 Withdrawn
5067 Withdrawn
5207 Withdrawn
5206 Withdrawn
5038 Withdrawn
5018 Withdrawn
5017 Withdrawn
5048 Withdrawn
5007 Withdrawn
5039 Withdrawn
5058 Withdrawn

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

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2019-05-10 Class II Under Investigation by firm The glass syringe used with Pressure Control Syringes may potentially break during use. 237 2020-06-05

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