Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instruments
Prenatal diagnostic instruments
EMDN code Z120801
Manufacturers registered in Europe (EUDAMED) 25
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 98
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K935301 (1994) |
| Huntleigh Healthcare, Inc. | United Kingdom | DOPPLEX OBIX SONICAID | K250777 (2025) |
| Coopersurgical, Inc. Present in Europe in other categories | United States | Summit Doppler MediChoice ClearTone Doppler TRIA II Display Doppler TRIA II Doppler ClearTone | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | LABSYSTEM™ PRO | K152693 (2015) |
| PERIGEN SOLUTIONS LTD | – | PeriWatch Vigilance® HUB™ PeriWatch Vigilance® Curve™ PeriWatch Vigilance® Cues™ PeriCALM® Patterns™ PeriWatch™ HUB™ PeriCALM® Curve™ | registered |
| CETRO AMERICA INC | United States | Cetro America Ultrasound Transducer for IM77/AM67, Waterproof Cetro America Toco Transducer for all Coro models Cetro America Toco Transducer for IM77/AM67, Waterproof Cetro America Toco Transducer for Sonomed Cetro America Ultrasound Transducer for FC6/8, FS6/8/10, Kranzbüler, Waterproof Cetro America Toco Transducer for IM76/AM66, Waterproof | K050826 (2006) |
| Vcomin Technlogy Limited | – | VCOMIN Fetal Doppler My Baby's Heartbeat Bear Fetal Doppler SOYES Fetal Doppler SpringBud Fetal Doppler Fetal Doppler FD-530G Fetal Doppler FD-530B | registered |
| KENTEC MEDICAL, INC. | United States | Ameritus Transducer | registered |
| Avante | – | Compact II Compact Plus Compact FM E-ST E-ST Pro | registered |
| Clinicomp, Inc. | United States | Fetal Monitor Remote Display Universal Data Acquisition System | K931133 (1995) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Tenacore Holdings, Inc. | United States | Tenacore Mothership Wireless Transducers, Button Style Mothership Wireless Transducers, Loop Style Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style Mothership Wireless Fetal Ultrasound Transducer, Button-Style Mothership Wireless Fetal Tocodynamometer Transducer, Button Style | K043075 (2005) |
| PERIGEN INC. | Israel | PeriWatch Tracings PeriWatch Surveillance PeriWatch Vigilance Tracings | K241009 (2025) |
| PARKS MEDICAL ELECTRONICS, INC. | United States | 2.25MHZ OB PROBE 641 2.15MHZ OB PROBE 641-A 2.20MHZ OB PROBE 641 2.25MHZ OB PROBE 641-A 2.00MHZ OB PROBE 641 2.10MHZ OB PROBE 641 | registered |
| PARKER-HANNIFIN CORPORATION | United States | FEATHERLITE TOCO FEATHERLITE TOCO PLUS FEATHERLITE AQUA | registered |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | NATUS NEUROLOGY | registered |
| CLINICAL INNOVATIONS, LLC Present in Europe in other categories | United States | Koala Toco® Koala® Cables Koala® | K250897 (2025) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED FETAL MONITOR ADVANCED CENTRAL MONITORING STATION ADVANCED POCKET DOPPLER ADVANCED DOPPLER | K141194 (2014) |
| Acist Medical Systems, Inc. Present in Europe in other categories | United States | RXi® Mini Navvus Interface Cable ACIST RXi® Mini System Overpack ACIST RXi® Mini Processing Unit ACIST RXi® Mini Mount ACIST RXi® Mini Navvus Interface | K172216 (2017) |
| Airstrip Technologies, LP | United States | AirStrip ONE AirStrip ONE Platform AirStrip ONE Client iOS AirStrip OB Legacy iOS AirStrip OB Legacy Server AirStrip ONE Client Android | K090269 (2009) |
| Utah Medical Products, Inc. Present in Europe in other categories | United States | INTRAN | K961424 (1996) |
| Cerner Corporation Present in Europe in other categories | United States | FetaLink+ FetaLink+® FetaLink | K121758 (2012) |
| American I.V. Products, Inc. | United States | AIV | K040392 (2004) |
| IMEX, LLC | United States | Imex 3MHZ DOPPLER PROBE,PD2 Imex 2MHZ Doppler Probe PD2 Imex 8MHZ DOPPLER PROBE, PD2 Imex Pocket Dop II Doppler System Imex 5MHZ DOPPLER PROBE, PD2 Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDII | registered |
| LORTE TECHNOLOGIES, INC | – | FaceLake | registered |
| Guangdong Biolight Meditech Co., Ltd. Present in Europe in other categories | China | Fetal monitor handheld monitor | K153580 (2016) |
| Clinical Computer Systems, Inc. | United States | OBIX Perinatal Data System | K121208 (2012) |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | MURAL PERINATAL SURVEILLANCE Centricity CareIntellect Perinatal CENTRICITY PERINATAL | K220732 (2022) |
| Sebe Inc | – | Neeva Baby | registered |
| Shenzhen Mericonn Technology Co., Ltd. Present in Europe in other categories | China | Mericonn | K212084 (2021) |
| DAGAMMA INC. | – | Baby Doppler | registered |
| EASY HEALTHCARE CORPORATION | – | Sweetiesong Fetal Doppler Sweetiesong Pocket Fetal Doppler | registered |
| GYNEX CORPORATION | United States | Sonotrax Pro Fetal Doppler Gynex Sonotrax Basic Fetal Doppler | registered |
| Mindchild Medical | United States | Meridian Cable Set Meridian M110 Fetal Monitoring System Meridian Disposable fECG Electrode Patch | K161902 (2017) |
| ALPHA SOURCE INC. | – | ALPHA SOURCE BATTERY | registered |
| Bionet Co., Ltd. Present in Europe in other categories | South Korea | FC700 FC1400 | K043597 (2005) |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | MIB II PROTOCOL CONVERTER IDS WITH INTERGRATED MIB | K050974 (2005) |
| MILLAR INC. | United States | Monitor Input Cable, Mikro-Cath to EP-Tracer System Pressure Control Unit PCU-2000 | registered |
| O.B - TOOLS LTD | Israel | TrueLabor Monitor Adapter TrueLabor Maternal Unit | K150398 (2015) |
| Philips Medical Systems Hsg | – | Avalon Fetal & Maternal Patch IntelliSpace Perinatal | registered |
| SIMPRO | – | NatureSpirit Care Mill | registered |
| VENNI INSTRUMENTS INC. | – | Venni / Biolight | registered |
| BEAR DOWN CONSULTING | – | PURE ENRICHMENT | registered |
| BOOT REMEDY LTD | – | Paryvara | registered |
| Beijing Choice Electronic Technology Co., Ltd. Present in Europe in other categories | China | ChoiceMMed | registered |
| Clinical Guard | – | Clinical Guard | registered |
| EBZNS HOLDINGS LLC | – | Little Martin's Drawer | registered |
| HATCH BABY, INC. | – | Fetal Doppler | registered |
| Hill-Rom, Inc. Present in Europe in other categories | United States | NaviCare® WatchChild® Systems | registered |
| MEDIBLU MEDICAL LLC | United States | Mediblu | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| MEDONE LLC | – | MedOne | registered |
| NK AMERICAN WAY, LLC | – | Bjingles | registered |
| Nihon Kohden America, Inc. Present in Europe in other categories | United States | CNS-2101 Central Monitor | registered |
| Nihon Kohden Digital Health Solutions, LLC Present in Europe in other categories | United States | Central Station | registered |
| Shenzhen AOJ Medical Technology Co., Ltd. Present in Europe in other categories | China | – | K182190 (2018) |
| Shenzhen Kairuigeli Investment Consultant Co., Ltd. | – | REFAGO | registered |
| Slv Pharmaceuticals LLC | – | NEONATAL | registered |
| Tenovi Co. | – | Tenovi | registered |
| Accumed Intl., Inc. | United States | – | registered |
| Alertwatch, LLC | United States | – | K173715 (2018) |
| Amphenol Alden Products Company | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Beijing Choice Electronic Technololgy Co., Ltd. | China | – | K112911 (2011) |
| Bloom Technologies NV | Belgium | – | K222327 (2023) |
| Borze, Inc. | United States | – | registered |
| CD Leycom | Netherlands | – | registered |
| China Qingdao Bright Medical Manufacturing CO.,Ltd. Present in Europe in other categories | China | – | registered |
| Creation Technologies | Canada | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| EDAN Diagnostics, Inc. | United States | – | registered |
| Farus, LLC | United States | – | K171865 (2017) |
| GWW | Germany | – | registered |
| HONG KONG MEDSOURCING LIMITED | Hong Kong SAR China | – | registered |
| Katecho, Inc. | United States | – | registered |
| LEBANESE INTERNATIONAL TECHNOLOGIES | Lebanon | – | registered |
| LUEN HING TEXTILE COMPANY LTD. | United States | – | registered |
| Leonhard Lang GmbH | United States | – | registered |
| MULTISOURCE MANUFACTURING LLC | United States | – | registered |
| Maquet Critical Care AB Present in Europe in other categories | United States | – | registered |
| Mindray DS USA, Inc. | United States | – | registered |
| Molex, LLC (Phillips Medsize) | United States | – | registered |
| NICOLAY GMBH | Germany | – | registered |
| Natus Medical Incorporated Present in Europe in other categories | United States | – | registered |
| Ninghai Guangjie Electronic Commerce Co., Ltd | China | – | registered |
| Philips Medizin Systeme Boeblingen GmbH | Germany | – | K233440 (2024) |
| Quipment | France | – | registered |
| Shenzhen Jamr Technology Co., Ltd. Present in Europe in other categories | China | – | K233823 (2024) |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | – | registered |
| Shenzhen Taikang Medical Equipment Co., Ltd. | China | – | K211940 (2022) |
| Shenzzhen Luckcome Technology Inc., Ltd. | China | – | K182710 (2019) |
| Sibel Health Inc. Present in Europe in other categories | United States | – | K253021 (2026) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| TIOGA LIMITED | United Kingdom | – | registered |
| Unitron Corp. | United States | – | registered |
| VELCROMEX, S.A. DE C.V. | Mexico | – | registered |
| WatchChild, LLC | United States | – | registered |
| Zhongshan Xiaolan Town Senlan Electronic Factory | China | – | K252669 (2026) |
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Related categories
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- Parent category : Obstetrics and gynaecology instruments129 manufacturers