Instruments for functional explorations and therapeutic interventionsGeneral medicine instrumentsGeneral medicine diagnosis and monitoring instruments
Equipment for diagnosis of the bioelectric functional state
EMDN code Z12040104
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 |
|---|---|---|---|---|
| InBody FDA EU representative : InBody Europe B.V. (Netherlands) | South Korea | IIa MDR | Website 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) 46
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 |
|---|---|---|---|
| TAYLOR PRECISION PRODUCTS, INC. | – | Taylor Homedics EatSmart Bowflex Brookstone Metro | registered |
| Conair Corp. | United States | CONAIR CONAIR CORPORATION | registered |
| Tanita Corp. of America Present in Europe in other categories | United States | TANITA/Ironman Body Composition Monitor TANITA Body Composition Analyzer TANITA Body Composition Monitor TANITA Body Fat Monitor TANITA/FitScan Body Composition Monitor Body Composition Analyzer | K100183 (2011) |
| Greater Goods | – | Weight Gurus Balance Greater Goods | registered |
| LIFESPAN BRANDS LLC | – | Detecto WeighRite | registered |
| Jarden Consumer Solutions | – | Health-O-Meter Sunbeam | registered |
| Shenzhen Unique Scales Co., Ltd | China | Analyzer,Body composition | registered |
| Bodystat , Ltd. Present in Europe in other categories | Brazil | Bodystat | K082254 (2011) |
| ImpediMed Limited Present in Europe in other categories | Australia | BioImp Body Composition Analysis Software SFB7 Imp SFB7 | K052319 (2006) |
| Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. | – | eufy belter efuy | registered |
| VISIOMED GROUP | France | BEWELL CONNECT MyScale BEWELL CONNECT MyBabyScale | registered |
| HTC AMERICA, INC. | – | HTC | registered |
| Omron Healthcare, Inc. Present in Europe in other categories | United States | Full Body Sensor Body Composition Monitor and Scale Omron Body Composition Monitor and Scale with Bluetooth | K062043 (2006) |
| ANDESFIT LIMITED | – | Andnesfit Health | registered |
| BETTER BASICS, INC. | – | Body fat scale | registered |
| COMMONPATH LLC | – | Ozeri | registered |
| SELVAS Healthcare, Inc. Present in Europe in other categories | South Korea | ACCUNIQ | registered |
| ADAM ELEMENTS INTERNATIONAL CO., LTD. | – | Transtek | registered |
| BEURER NORTH AMERICA, L.P. | – | Beurer | registered |
| CEREBROTECH MEDICAL SYSTEMS INC | – | Cerebrotech Fluids Monitor | registered |
| ESCALI CORP | – | Escali | registered |
| Ld Technology, LLC Present in Europe in other categories | United States | ES-BC | K103026 (2011) |
| QARDIO, INC. | United States | QardioBase | registered |
| Shenzhen NearbyExpress Technology Development Company Limited | – | TAOTRONICS Wireless Body Composition Smart Scale | registered |
| Shenzhen Pump Medical System Co., Ltd. Present in Europe in other categories | China | IGuerburn | registered |
| Star Elite Inc | Canada | Sunbeam | registered |
| VALUE PROVIDERS LLC | – | Eocene | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | VIVE | registered |
| WALGREEN CO. | – | Well at Walgreens | registered |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVS Health | registered |
| Andon Health Co, Ltd. Present in Europe in other categories | China | – | K120896 (2012) |
| CHA'S ELECTRONIC INDUSTRIES (SHENZHEN) COMPANY LIMITED | China | – | registered |
| Conmo Electronic Company Limited | China | – | K140594 (2014) |
| EMSAR | United States | – | registered |
| Fitbit LLC Present in Europe in other categories | United States | – | K133872 (2014) |
| Fook Tin Technologies Limited | Hong Kong SAR China | – | K083838 (2009) |
| Guangdong Transtek Medical Electronics Co., Ltd. Present in Europe in other categories | China | – | K131394 (2013) |
| Higi Sh, LLC | United States | – | registered |
| Krell Precision (Yang Zhou) Co., Ltd. | United States | – | K081587 (2008) |
| MEASUREMENT LTD. | Hong Kong SAR China | – | registered |
| OnCore Manufacturing LLC | United States | – | registered |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd | China | – | registered |
| Shenzhen Healthcare Electronic Technology Co., Ltd. | China | – | K121527 (2012) |
| Shenzhen Shine Industrial Co., Ltd. | China | – | registered |
| Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Present in Europe in other categories | China | – | K231116 (2024) |
| seca GmbH & Co. KG Present in Europe in other categories | United States | – | K122388 (2013) |
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