Zacurate

Fingertip Pulse Oximeter (500BL)

Registry build 21.09.26
29manufacturers in China registered for this device type
26catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (18), Beijing (2), Tianjin (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OCH
Manufacturer City Province Registered as Device types
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Shenzhen Changkun Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Hunan Accurate BIO-Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 7
Beijing Choice Electronic Technololgy Co., Ltd. Beijing Beijing Repacker / relabeller 30
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Contec Medical Systems Co., Ltd. Qinhuangdao Hebei Manufacturer 22
Guangdong Biolight Meditech Co., Ltd. Zhuhai Guangdong Manufacturer 19
Avita (Wujiang) Co., Ltd. Wujiang Jiangsu Contract manufacturer 15
Xuzhou Yongkang Electronic Science Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 13
Shenzhen Yuezhongxing Technology Co., Ltd. Huizhou Guangdong Repacker / relabeller 10
Shenzhen Creative Industry Co., Ltd. Shenzhen Guangdong Manufacturer 9
Shenzhen Jumper Medical Equipment Co., Ltd. Shenzhen Guangdong Repacker / relabeller 9

Showing 12 of 29. All 29 manufacturers in China registered for Oximeter, Infrared, Sporting, Aviation

Record

Regulatory record for Zacurate
Listed by Einstein Associates LLC
FDA product code OCH
Device type Oximeter, Infrared, Sporting, Aviation
Device class Class 2
Regulation 21 CFR 870.2700
Premarket notification Exempt
Record published 2025-01-28
Record revised 2021-11-10 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Zacurate
Catalogue number Size Status
500BL In distribution
400B In distribution
500D Blue In distribution
500E purple In distribution
500E White In distribution
500DL-M Black In distribution
500DL Purple In distribution
500E Purple In distribution
500CL In distribution
500DL Blue In distribution
430/DL In distribution
500DL Black In distribution
430P In distribution
500DL Black In distribution
500DL Pink In distribution
500DL Purple In distribution
500DL Pink In distribution
500B In distribution
500D Pink In distribution
500B-B In distribution
500E-B In distribution
500C Black In distribution
500D Black In distribution
500E Pink In distribution
500E Black In distribution
500D Purple In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Contec Contec Medical Systems Co., Ltd. 21
mibest Beijing Choice Electronic Technology Co., Ltd. 13
Pulse Oximeter Shenzhen Creative Industry Co., Ltd. 13
Pulse Oximeter Shenzhen Viatom Technology Co., Ltd. 12
Concord Contec Medical Systems Co., Ltd. 12
Accurate® Hunan Accurate BIO-Medical Technology Co., Ltd. 10
Acc U Rate Health Connector LLC 10
ChoiceMMed Beijing Choice Electronic Technology Co., Ltd. 9
CVS Health Woonsocket Prescription Center, Incorporated 8
Santamedical Gurin Products LLC 8
Concord Beijing Choice Electronic Technology Co., Ltd. 8
Zacurate Health Connector LLC 7

Showing 12 of 100. All products under Oximeter, Infrared, Sporting, Aviation

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