AdviewII™

Adview2 Diagnostic Station,BP/SpO2 Masimo Set/Temp Modules

Registry build 21.09.26
98manufacturers in China registered for this device type
42catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXN
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Taizhou Rich Medical Products Co., Ltd. Taizhou Jiangsu Contract manufacturer 20
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 7
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Shenzhen Brav Electronic Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive

Record

Regulatory record for AdviewII™
Listed by American Diagnostic Corp., United States
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
510(k) K160439
Record published 2018-04-27
Record revised 2019-11-08 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment humidity 15 to 85 % RH; Storage environment temperature -4 to 131 °F
Distribution end date 2019-04-19

Catalogue Numbers

Catalogue numbers for AdviewII™
Catalogue number Size Status
9005-10SARB-1MB Small Adult, 17-25cm In distribution
9005M In distribution
9005CKP Child-Adult, 12-33cm In distribution
9005SCAN In distribution
9005-11AN-1MB Adult, 23-33cm In distribution
9005BPS 2 Cuff, 28-55cm In distribution
9005USB In distribution
9005BPSTO 2 Cuff, 28-55cm In distribution
9005TRK In distribution
9005TWR In distribution
9005-11APN-1MB Adult Plus, 28-40cm In distribution
9005-12XPBD-1MB Large Adult Plus, 40-55cm In distribution
9005TO In distribution
9005-9CGR-1MB Child, 12-19cm In distribution
9005-12XBD-1MB Large Adult, 31-40cm In distribution
9005PSHELF In distribution
9005CK Child-Thigh, 12-50cm In distribution
9005SCANL In distribution
9005S In distribution
9005W In distribution
9005BPCN 2 Cuff, 28-55cm In distribution
9005DON In distribution
9005BPSMTO In distribution
9005TWB In distribution
9005PAPER In distribution
9005BP 2 Cuff, 28-55cm In distribution
9005BAT In distribution
9005P In distribution
9005BPC In distribution
9005PC In distribution
9005TCP In distribution
9005SM In distribution
9005-13TBR-1MB Thigh, 38-50cm In distribution
9005TOK In distribution
9005BPSM In distribution
9005SCN In distribution
9005BPTO 2 Cuff, 28-55cm In distribution
9005SCAN2D In distribution
9005TR In distribution
9005CKA Small Adult-Large Adult, 17-40cm In distribution
9005D In distribution
9005SPDYS Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Baum W.A. Baum Co., Inc. 116
Alphamed Shenzhen Urion Technology Co., Ltd. 68
Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co., Ltd. 59
Arm Type Automatic Blood Pressure Monitor Shenzhen Jiacom Technology Co., Ltd. 58
A&D Medical A&D Company, Ltd. 56
Diagnostix™ American Diagnostic Corp. 54
Lutech Lutech Industries 51
Veridian Veridian Healthcare 50
Hopkins Medical Products® Hopkins Uniform Company 49
Welch Allyn, Inc. Welch Allyn, Inc. 49
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 48
SunTech Suntech Medical, Inc. 46

Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive

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