Dopplex
Antepartum Fetal Monitor BD4000XS-2/USA
6manufacturers in China registered for this device type
9catalogue numbers in this listing
13510(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.
| 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 | Huntleigh Healthcare Ltd., United Kingdom |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K001882 |
| Record published | 2016-08-22 |
| Record revised | 2026-05-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 40 °C; Handling environment temperature -10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CT1L | In distribution | |
| ACC7 | In distribution | |
| BD4000AXS-2/USA | In distribution | |
| BD3002-USA | In distribution | |
| FM830-SL-ENCORE | In distribution | |
| CT1 | In distribution | |
| EM1 | In distribution | |
| FM820-SL-ENCORE | In distribution | |
| US1 | 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 |
| Mini Telemetry System | Wipro GE Healthcare Private Ltd. | 8 |
| Natus Neurology | Natus Neurology Incorporated | 8 |
| Fetal & maternal monitor | Edan Instruments, Inc. | 8 |
| PeriWatch Vigilance® Curve™ | PeriGen Solutions Ltd. | 8 |
Showing 12 of 117. All products under System, Monitoring, Perinatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250777 | 2025-09-19 |
| K241368 | 2025-02-03 |
| K200975 | 2020-06-24 |
| K132650 | 2014-02-07 |
| K090285 | 2009-07-15 |
| K060230 | 2006-03-23 |
| K010894 | 2001-04-25 |
| K010889 | 2001-04-25 |
| K001882 | 2000-09-19 |
| K990569 | 2000-01-24 |
| K963711 | 1997-09-12 |
| K823188 | 1983-01-26 |
| K823081 | 1983-01-26 |
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.