ECG

V-PAK Preconnected V Lead Electrodes FOR 12 Lead, 6 Electrode SET / Pouch

Registry build 21.09.26
33manufacturers in China registered for this device type
39catalogue 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 ECG
Listed by Zoll Medical Corporation, United States
FDA product code DRX
Device type Electrode, Electrocardiograph
Device class Class 2
Regulation 21 CFR 870.2360
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-08-03
Record revised 2026-02-17 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Handling environment temperature 0 to 0 °C; Storage environment atmospheric pressure from 0 KiloPascal; Storage environment temperature 0 to 0 °C; Storage environment humidity 0 to 0 % RH
Packaging Pack of 10, pack of 20, pack of 12, pack of 17, pack of 4
Distribution end date 2026-01-01
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ECG
Catalogue number Size Status
9600-0701 In distribution
9600-0700 In distribution
9600-0200-30 In distribution
9600-0155 In distribution
9600-0703-01 In distribution
9600-0166 In distribution
9600-0701 In distribution
9600-0200-30 In distribution
9600-0166 In distribution
9600-0709 In distribution
9600-0704 In distribution
9600-0160 In distribution
9600-0704 In distribution
9600-0709 In distribution
9600-0706 In distribution
9600-0230 In distribution
9600-0225 In distribution
9600-0706 In distribution
9600-0160 In distribution
9600-0703-01 In distribution
9600-0235 In distribution
9600-0201-30 In distribution
9600-0235 Withdrawn
9600-0714 Withdrawn
9600-0715 Withdrawn
9600-1300-01 Withdrawn
9600-0230 Withdrawn
9600-0700 Withdrawn
9600-0702 Withdrawn
9600-0155 Withdrawn
9600-1300-01 Withdrawn
9600-0225 Withdrawn
9600-0707 Withdrawn
9600-0700 Withdrawn
9600-0155 Withdrawn
9600-0708 Withdrawn
9600-0225 Withdrawn
9600-0230 Withdrawn
9600-0235 Withdrawn

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
Ambu WhiteSensor Medico Electrodes International Ltd 51
Z-Brand™ Graphic Controls Acquisition Corporation 48
S&W Leonhard Lang Gmbh 47
Vermed Graphic Controls Acquisition Corporation 45

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