Beurer

BM67 Bluetooth® Upper Arm Blood Pressure Monitor * with standard cuff 8.7 - 14.2 in (22 - 36 cm) * with universal cuff size 8.7 - 17.3 in (22 - 44 cm)

Registry build 21.09.26
98manufacturers in China registered for this device type
30catalogue 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 Beurer
Listed by Beurer North America, L.P.
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
Record published 2023-10-20
Record revised 2020-03-31 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, serial number
Storage Storage environment temperature -4 to 122 °F; Storage environment humidity up to 85 % RH; Storage environment temperature -20 to 50 °C; Handling environment temperature 50 to 104 °F; Handling environment temperature 10 to 40 °C; Handling environment humidity up to 85 % RH
Packaging Case pack of 4, case pack of 8, inner pack of 4, case pack of 50, inner case of 4, inner pack of 6
Distribution end date 2020-01-13

Catalogue Numbers

Catalogue numbers for Beurer
Catalogue number Size Status
BM27 In distribution
BM47 Universal Cuff (replacement) In distribution
CBC30 In distribution
Deluxe 600 In distribution
BM69W In distribution
BM67 In distribution
BM47 XL Cuff (replacement) (Item No. 163.859) In distribution
Auto 400 In distribution
BC22 In distribution
BC54 In distribution
BC30 (Art.-No.650.70) In distribution
BC21 In distribution
BM69 In distribution
BM81 In distribution
BM52W In distribution
BM31 In distribution
BM28 In distribution
BM26 In distribution
BM54 In distribution
BM50 In distribution
BM47 Blood Pressure Monitor with Universal Cuff In distribution
BM76 In distribution
BC81 In distribution
PREMIUM 800W In distribution
BM55 In distribution
BC87W In distribution
PREMIUM 800 In distribution
BC57 (Art.-No. 656.74) In distribution
BM35 XL Cuff (replacement) In distribution
BM35 XL Cuff (replacement) (Art.- No. 162.934) 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