Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instrumentsPrenatal diagnostic instruments
Foetal heartbeat detectors
EMDN code Z12080103
Manufacturers registered in Europe (EUDAMED) 15
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Contecmed FDA EU representative : Prolinx GmbH (Germany) | China | IIa MDR, 93/42 | Website pms.qms@contecmed.com EUDAMED record Report an error | |
| Bistos FDA EU representative : Obelis s.a. (Belgium) | South Korea |
|
IIa 93/42 | Website EUDAMED record Report an error |
| Meditech FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | IIa 93/42 | Website sales@meditech.cn EUDAMED record Report an error | |
| Shenzhen Unicare Electronic EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIa MDR | Website EUDAMED record Report an error | |
| Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIa MDR | EUDAMED record Report an error | |
| Laerdal FDA | Norway | IIa 93/42 | Website PRRC@laerdal.com EUDAMED record Report an error | |
| Shenzhen IMDK Medical Technology FDA EU representative : MedNet EC-REP GmbH (Germany) | China |
|
IIa 93/42 | service@imdker.com EUDAMED record Report an error |
| Shenzhen Jumper Medical Equipment FDA EU representative : MedPath GmbH (Germany) | China |
|
IIa MDR | EUDAMED record Report an error |
| Sonomed FDA | Poland | IIa 93/42 | Website EUDAMED record Report an error | |
| Biocare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIa 93/42 | regulation@biocare.com.cn EUDAMED record Report an error | |
| HeraMED FDA EU representative : Obelis s.a. (Belgium) | Israel |
|
IIa 93/42 | Website info@hera-med.com EUDAMED record Report an error |
| Hunan Accurate Bio-Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIa MDR | regulation@accbiomed.com EUDAMED record Report an error |
| medical ECONET | Germany |
|
IIa 93/42 | Website info@medical-econet.com EUDAMED record Report an error |
| Shenzhen Bestman Instrument FDA EU representative : Lotus NL B.V. (Netherlands) | China | IIa MDR | EUDAMED record Report an error | |
| Vcomin FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIa MDR | Website info@vcomin.com EUDAMED record Report an error |
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) 39
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 |
|---|---|---|---|
| Coopersurgical, Inc. Present in Europe in other categories | United States | Summit Doppler MediChoice ClearTone Doppler TRIA II Display Doppler TRIA II Doppler ClearTone | registered |
| 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 |
| Huntleigh Healthcare, Inc. | United Kingdom | DOPPLEX SONICAID | K930200 (1994) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Avante | – | E-ST E-ST Pro | registered |
| 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 |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | NATUS NEUROLOGY | registered |
| Sebe Inc | – | Neeva Baby | registered |
| Shenzhen Mericonn Technology Co., Ltd. Present in Europe in other categories | China | Mericonn | K212084 (2021) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED POCKET DOPPLER ADVANCED DOPPLER | K112529 (2011) |
| 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 |
| SIMPRO | – | NatureSpirit Care Mill | 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 |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| MEDONE LLC | – | MedOne | registered |
| NK AMERICAN WAY, LLC | – | Bjingles | 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 |
| Arjohuntleigh AB Present in Europe in other categories | United Kingdom | – | registered |
| Beijing Choice Electronic Technololgy Co., Ltd. | China | – | K112911 (2011) |
| Borze, Inc. | United States | – | registered |
| EDAN Diagnostics, Inc. | United States | – | registered |
| HONG KONG MEDSOURCING LIMITED | Hong Kong SAR China | – | registered |
| Natus Medical Incorporated Present in Europe in other categories | United States | – | registered |
| Ninghai Guangjie Electronic Commerce Co., Ltd | China | – | registered |
| Shenzhen Jamr Technology Co., Ltd. Present in Europe in other categories | China | – | K233823 (2024) |
| Shenzhen Taikang Medical Equipment Co., Ltd. | China | – | K211940 (2022) |
| Shenzzhen Luckcome Technology Inc., Ltd. | China | – | K182710 (2019) |
| Zhongshan Xiaolan Town Senlan Electronic Factory | China | – | K252669 (2026) |
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