An electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvas
| Company | Devices | Share |
|---|---|---|
| Huntleigh Healthcare Limited | 59 | 38% |
| Kentec Medical, Inc. | 27 | 18% |
| Cetro America Inc | 24 | 16% |
| Tenacore Holdings, Inc. | 10 | 6% |
| Wipro Ge Healthcare Private Limited | 9 | 6% |
| Edan Instruments, Inc. | 6 | 4% |
| Guangdong Biolight Meditech Co., Ltd. | 4 | 3% |
| Philips Medizin Systeme Böblingen Gmbh | 4 | 3% |
| Datex-Ohmeda, Inc. | 4 | 3% |
| Venni Instruments Inc. | 2 | 1% |
| Nuvo Group Usa, Inc. | 1 | 1% |
| Mindchild Medical | 1 | 1% |
Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| HGM | System, Monitoring, Perinatal | 141 |
| HGM | SYSTEM, MONITORING, PERINATAL | 8 |
| OSP | Uterine Electromyographic Monitor | 5 |
| HEL | MONITOR, HEART RATE, FETAL, ULTRASONIC | 5 |
| HFM | MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) | 4 |
| HGM | System, monitoring, perinatal | 3 |
Use these as the dimensions to specify in a tender line.
154 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Foetal/maternal prenatal monitor", from 15 companies. The largest labeler is Huntleigh Healthcare Limited with 38% of records.
HGM (System, Monitoring, Perinatal), HGM (SYSTEM, MONITORING, PERINATAL), OSP (Uterine Electromyographic Monitor), HEL (MONITOR, HEART RATE, FETAL, ULTRASONIC)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.