Avalon Fetal Monitor FM20
Avalon FM20 Fetal Monitor for external Fetal Monitoring
6manufacturers in China registered for this device type
1catalogue number
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.
| 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
| Listed by | Philips Medizin Systeme Böblingen GmbH, Germany |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Record published | 2016-10-03 |
| Record revised | 2023-05-05 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 15 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Avalon FM20 Fetal Monitor | In distribution |
Same 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2026-05-26 | Class II | Process control | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | 285 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.