Easy Plus II Control Solution – LOW

Blood glucose control solution for use with Easy Plus II blood glucose testing system

Registry build 21.09.26
20manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NBW
Manufacturer City Province Registered as Device types
Acon Biotech (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Sanmina Kunshan Jiangsu Contract manufacturer 15
Dongguan Honfield Precision Parts Co., Ltd. Zhangmutou, Dongguan Guangdong Contract manufacturer 8
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Flextronics Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Yasee Biomedical Inc Qingdao Shandong Contract manufacturer 5
Altek Medical (kunshan) limited Kunshan Free Trade Zone Jiangsu Contract manufacturer 2
Dongguan Kaifa Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Vivachek Biotech (Hangzhou) Co., Ltd. Hangzhou, Zhuji Zhejiang Contract manufacturer 21

Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter

Record

Regulatory record for Easy Plus II Control Solution – LOW
Listed by Home Aide Diagnostics, Inc., United States
FDA product code NBW
Device type System, Test, Blood Glucose, Over The Counter
Device class Class 2
Regulation 21 CFR 862.1345
Establishment Repacker / relabeller
Record published 2016-05-01
Record revised 2018-06-14 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Store at temperatures between 46-86oF (8-30oC).
Packaging Inner case of 100, outer case of 20
Sizes Total volume 3 ml

Catalogue Numbers

Catalogue numbers for Easy Plus II Control Solution – LOW
Catalogue number Size Status
GOD11 Total Volume 3 ml In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
True Metrix Trividia Health, Inc. 40
Fora Fora Care Inc. 31
True Metrix AIR Trividia Health, Inc. 21
GE Bionime Corporation 21
TRUEtrack Trividia Health, Inc. 17
Medline Medline Industries, Inc. 15
AgaMatrix Agamatrix 15
Tenovi Tenovi Co 13
Auvon Shenzhen Yuwen E-Commerce Co., Ltd. 11
Accu-Chek Guide Roche Diagnostics Operations 10
Curaplex Bound Tree Medical, LLC 10
OneTouch Verio Lifescan Europe Gmbh 10

Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter

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