Ambu WhiteSensor

Electrocardiographic electrode, single use

Registry build 21.09.26
33manufacturers in China registered for this device type
51catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (12), Jiangsu (6), Zhejiang (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRX
Manufacturer City Province Registered as Device types
China Qingdao Bright Medical Manufacturing Co., Ltd. Qingdao Shandong Contract manufacturer 8
Linxens Healthcare (Tianjin) Co., Ltd. Jinnan District Tianjin Contract manufacturer 7
Dongguan Ruibaolian Medical Science & Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Shanghai Yuechen Medical Supply Co..ltd. Shanghai Shanghai Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
Shanghai NEO-Medical Import & Export Co., Ltd. Shanghai Shanghai Exporter 59
Ningbo Chibanda IMP &EXP Co., Ltd. Ningbo Zhejiang Manufacturer 59

Showing 12 of 33. All 33 manufacturers in China registered for Electrode, Electrocardiograph

Record

Regulatory record for Ambu WhiteSensor
Listed by Medico Electrodes International Ltd, India
FDA product code DRX
Device type Electrode, Electrocardiograph
Device class Class 2
Regulation 21 CFR 870.2360
Establishment Manufacturer
Premarket notification Exempt
Record published 2020-08-20

Specifications

Specifications
MRI safety MR Conditional
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 5 to 30 °C; Storage environment temperature 41 to 86 °F
Packaging Pack of 6, pack of 10, pack of 12, pack of 200, pack of 5, pack of 150

Catalogue Numbers

Catalogue numbers for Ambu WhiteSensor
Catalogue number Size Per pack Status
4440/5 5 In distribution
7841P/5 5 In distribution
4560M 60 In distribution
7841P/3 3 In distribution
WS-00-S/30 30 In distribution
WS-00-S/50 50 In distribution
4570M 30 In distribution
WS-00-S/5 5 In distribution
4200 100 In distribution
4535M 60 In distribution
4242-00-S/50 50 In distribution
0615M 100 In distribution
0315M 100 In distribution
4841P 60 In distribution
4500M 30 In distribution
4831Q 60 In distribution
CMM/1-00-S/30 30 In distribution
WS-00-S/3 3 In distribution
WSP30-00-S/50 50 In distribution
7841P 60 In distribution
0715M 100 In distribution
5050-00-S/3 3 In distribution
4535M/5 5 In distribution
3245D/RT/60 60 In distribution
4440/3 3 In distribution
5050-00-S/50 50 In distribution
WS-00-S/L5/50 50 In distribution
5050-00-S/10 10 In distribution
4242-00-S/5 5 In distribution
WSP25-00-S/50 50 In distribution
WS-00-S/10 10 In distribution
4535M/3 3 In distribution
4500M-H/10 10 In distribution
WS-00-S/4 4 In distribution
WSP30-00-S/5 5 In distribution
2121M 500 In distribution
0215M 100 In distribution
5050-00-S/5 5 In distribution
4242-00-S/3 3 In distribution
WS-00-S/RT/5 5 In distribution
WS-00-S/RT/3 3 In distribution
4500M-H/5 5 In distribution
0415M 100 In distribution
4440 30 In distribution
4500M/5 5 In distribution
WSP30-00-S/3 3 In distribution
4500M-H/3 3 In distribution
WS-00-S/RT/50 50 In distribution
4500M/3 3 In distribution
4500M-H 60 In distribution
4242-00-S/10 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
APK APK Technology Co., Ltd. 113
Electrode, Electrocardiograph Fiab SPA 109
Swaromed Tyrolmed GmbH 93
MediMax Tech Medimax Tech Inc. 91
Kendall Cardinal Health 91
Medline Medline Industries, Inc. 78
AMC LifeSync Corporation 74
Kendall Cardinal Health 200, LLC 73
Z-Brand™ Graphic Controls Acquisition Corporation 48
S&W Leonhard Lang Gmbh 47
Vermed Graphic Controls Acquisition Corporation 45
Red Dot™ 3M Company 44

Showing 12 of 337. All products under Electrode, Electrocardiograph

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