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Emdyca

Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instrumentsPrenatal diagnostic instruments

Cardiotocographic telemetry instruments

EMDN code Z12080104

3 manufacturers, 4 models including 4 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 3
  • 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.
ManufacturerCountryRegistered modelsClassContact
Nestmedic Poland IIa MDR Website office@nestmedic.com EUDAMED record Report an error
Datex-Ohmeda FDA EU representative : GE Medical Systems SCS (France) United States IIb MDR eudamed@gehealthcare.com EUDAMED record Report an error
GE Healthcare FDA EU representative : GE Medical Systems SCS (France) India I MDR eudamed@gehealthcare.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) 35

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.

ManufacturerCountryBrandsFDA clearance
Boston Scientific Corp Present in Europe in other categories United States LABSYSTEM™ PRO K152693 (2015)
Edan Instruments, Inc. Present in Europe in other categories China Ultrasound Transducer US Transducer Fetal monitor TOCO Transducer Fetal & Maternal Module registered
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
CLINICAL INNOVATIONS, LLC Present in Europe in other categories United States Koala Toco® Koala® Cables Koala® K250897 (2025)
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)
Utah Medical Products, Inc. Present in Europe in other categories United States INTRAN K961424 (1996)
American I.V. Products, Inc. United States AIV K040392 (2004)
Huntleigh Healthcare, Inc. United Kingdom DOPPLEX registered
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
ADVANCED INSTRUMENTATIONS, INC. United States ADVANCED FETAL MONITOR registered
Avante – Compact II 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
Philips Medical Systems Hsg – Avalon Fetal & Maternal Patch registered
Amphenol Alden Products Company United States – registered
Amphenol Critical Medical Technologies, LLC United States – registered
Arjohuntleigh AB Present in Europe in other categories United Kingdom – registered
Bistos Co., Ltd. Present in Europe in other categories United States – registered
Borze, Inc. United States – registered
CD Leycom Netherlands – registered
Creation Technologies Canada – registered
DHL Supply Chain (Netherlands) B.V. Netherlands – registered
EDAN Diagnostics, Inc. United States – registered
GWW Germany – 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
Orantech Inc. Present in Europe in other categories China – registered
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories China – registered
Siemens Healthineers AG Present in Europe in other categories Germany – registered
Unitron Corp. United States – registered

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