Who else makes this device?

Name: Meridian M110 Fetal Monitoring System
Brand: Meridian M110 Fetal Monitoring System

Obstetrics & Gynecology › MonitoringSystem, Monitoring, Perinatal

Meridian M110 Fetal Monitoring System

The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions…

Registry build 21.09.26

The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MERIDIAN M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals.

6manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HGM
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Luen Hing Textile -Shangyu Manufacturing(ZHONG Shan) Co Ltd	Zhongshan	Guangdong	Contract manufacturer	2
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40
China Qingdao Bright Medical Manufacturing Co., Ltd.	Qingdao	Shandong	Contract manufacturer	8

Record

Regulatory record for Meridian M110 Fetal Monitoring System
Listed by	Mindchild Medical, United States
FDA product code	HGM
Device type	System, Monitoring, Perinatal
Device class	Class 2
Regulation	21 CFR 884.2740
Premarket notification	Exempt
Record published	2017-06-06
Record revised	2022-11-28 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	serial number
Packaging	Mixed case

Catalogue Numbers

Catalogue numbers for Meridian M110 Fetal Monitoring System
Catalogue number	Size	Status
M110		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
R&D Batteries, Inc.	R & D Batteries, Inc.	137
Sonicaid	Huntleigh Healthcare Ltd.	39
Obix	Huntleigh Healthcare Ltd.	33
Ameritus Transducer	Kentec Medical, LLC	28
Fetal Monitor Remote Display	Clinicomp Intl., Inc.	18
Tenacore	Tenacore LLC	11
FetaLink	Cerner Corporation	9
PeriWatch Vigilance® HUB™	PeriGen Solutions Ltd.	9
Dopplex	Huntleigh Healthcare Ltd.	9
Mini Telemetry System	Wipro GE Healthcare Private Ltd.	8
Natus Neurology	Natus Neurology Incorporated	8
Fetal & maternal monitor	Edan Instruments, Inc.	8

Showing 12 of 117. All products under System, Monitoring, Perinatal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161902	2017-01-12
K142883	2015-04-17
K120018	2012-09-19

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.