Obstetrics and gynaecology instrumentsPrenatal diagnostic instrumentsCardiotocographic telemetry instruments
Cardiotocographic telemetry instruments - other
EMDN code Z1208010499
Manufacturers registered in Europe (EUDAMED) 1
- 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 |
|---|---|---|---|---|
| Philips FDA | Germany | I, IIb MDR, 93/42 | eudamed@philips.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) 38
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 |
|---|---|---|---|
| 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) |
| Wipro GE Healthcare Private, Ltd. Present in Europe in other categories | United States | TOCO TRANSDUCER | registered |
| 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 |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | – | 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 |
| GE HealthCare Technologies Inc. Present in Europe in other categories | 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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Related categories
- Cardiotocographic telemetry instruments - consumables3 manufacturers
- Complete cardiotocographic telemetry systems1 manufacturer
- Transmitting units for cardiotocographic telemetry1 manufacturer
- Cardiotocographic telemetry instruments - hardware accessories1 manufacturer
- Receiving units for cardiotocographic telemetry1 manufacturer
- Parent category : Cardiotocographic telemetry instruments3 manufacturers