Midmark IQecg® Digital ECG

The IQecg®from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient information you need to make informed cardiac…

Registry build 21.09.26

The IQecg®from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient information you need to make informed cardiac assessments and provide more efficient patient care. Kit includes: Midmark IQecg – USB Version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable EZ-Trode ECG Electrodes.

18manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DPS
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Regent Electron Suzhou Co., Ltd. Wujiang Jiangsu Contract manufacturer 5
Ryder Electronics (Shenzhen) Ltd. Shenzhen Guangdong Contract manufacturer 5
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Beijing Choice Electronic Technololgy Co., Ltd. Beijing Beijing Repacker / relabeller 30
Shenzhen Comen Medical Instruments Co., Ltd. Shenzhen Guangdong Contract manufacturer 24

Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph

Record

Regulatory record for Midmark IQecg® Digital ECG
Listed by Midmark Corporation, United States
FDA product code DPS
Device type Electrocardiograph
Device class Class 2
Regulation 21 CFR 870.2340
Establishment Specification developer, Repacker / relabeller, Manufacturer
Record published 2016-09-24
Record revised 2021-03-10 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries manufacturing date, serial number
Storage Special storage condition: Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.; Storage environment humidity 30 to 90 % RH; Storage environment temperature -15 to 50 °C

Catalogue Numbers

Catalogue numbers for Midmark IQecg® Digital ECG
Catalogue number Size Status
1-100-1325 3.5″ x 5.7″ x 1.2″; Weight: 10.2 oz. In distribution
1-100-1330 In distribution
4-000-0061 3.5″ x 5.7″ x 1.2″; Weight: 10.2 oz. In distribution
4-000-0062 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 1,734
M Series Biphasic Zoll Medical Corporation 93
ELI 380 Mortara Instrument, Inc. 69
Patient Cable Lead Set Mortara Instrument, Inc. 56
ELI 250c Mortara Instrument, Inc. 50
Lutech Lutech Industries 49
ELI 150c Mortara Instrument, Inc. 47
Fukuda Denshi Fukuda Denshi Co., Ltd. 41
ELI 280 Mortara Instrument, Inc. 41
Electrocardiograph Edan Instruments, Inc. 38
Q-Stress Mortara Instrument, Inc. 25
XScribe Mortara Instrument, Inc. 22

Showing 12 of 177. All products under Electrocardiograph

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Midmark IQecg® Digital ECG
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Midmark Corporation UDI-DI 2026-07-20 Class II Software design A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. 3624 units

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