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US
Last updated May 25, 2026
What Esaote Europe B.V. makes
Esaote Europe B.V. manufactures general-purpose ultrasound imaging systems, including portable and handheld extracorporeal transducers, as well as specialized rectal and vaginal ultrasound probes. Their product line includes systems like the MyLabSix and MyLabOne series, designed for vascular and general diagnostic imaging, alongside standalone transducers such as the SL3413 and CA1421.
These devices are classified as Class II under regulatory frameworks, with authorizations granted through FDA 510(k) and UDI listings. The company’s portfolio is primarily regulated in the United States, where these systems are intended for medical imaging applications.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Esaote Europe B.V. manufacture?
Esaote Europe B.V. specializes in ultrasound imaging technology, producing general-purpose ultrasound imaging systems like the MyLabSix and MyLabOne series. Their portfolio also includes extracorporeal ultrasound transducers, such as handheld devices and specialized rectal/vaginal probes (e.g., SL3413 and CA1421). These devices are designed for diagnostic imaging across various medical applications, including vascular and general-purpose use.
Where is Esaote Europe B.V. based, and what regulatory regions do their devices operate in?
Esaote Europe B.V. is based in the United States. Their devices are primarily regulated and authorized in this region, where they undergo FDA review processes. The company’s products are listed under FDA 510(k) submissions and UDI (Unique Device Identification) registries, ensuring compliance with U.S. medical device regulations.
Which regulatory registries list Esaote Europe B.V.’s ultrasound devices?
Esaote Europe B.V.’s devices are included in the FDA’s 510(k) premarket notification registry and the UDI (Unique Device Identification) system. These registries track authorized medical devices in the U.S., ensuring transparency and compliance with regulatory requirements for Class II ultrasound systems.
How are Esaote Europe B.V.’s ultrasound devices classified under regulatory frameworks?
Esaote Europe B.V.’s ultrasound devices fall under Class II classification in regulatory frameworks like the FDA. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as pre-market notification (510(k)) reviews and UDI compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 404392797
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MyLabSix | 102642000 | FDA UDI | Class II | Active |
| MyLabOne Vascular | 102810015 | FDA UDI | Class II | Active |
| MyLab40 eHD | 102276000 | FDA UDI | Class II | Active |
| MyLabTouch | 102810020 | FDA UDI | Class II | Active |
| Sl3413 | 122001500 | FDA UDI | Class II | Active |
| MyLabOne Vascular USA | 102810022 | FDA UDI | Class II | Active |
| Main Unit MyLabOne Double battery | 102810091 | FDA UDI | Class II | Active |
| MyLabOne | 102810019 | FDA UDI | Class II | Active |
| MyLab40 | 102276001 | FDA UDI | Class II | Active |
| Ca1421 | 411395 | FDA UDI | Class II | Active |
| MyLabOne BASIC UNIT | 112810000 | FDA UDI | Class II | Active |
| MyLabSat USA | 102810018 | FDA UDI | Class II | Active |
| MyLabOne Musculoskeletal | 102810014 | FDA UDI | Class II | Active |
| MyLabTouch USA | 102810023 | FDA UDI | Class II | Active |
| MyLabFive BASIC UNIT | 411776 | FDA UDI | Class II | Active |
| MyLabSat | 102810013 | FDA UDI | Class II | Active |
| MyLab20 Plus | 102276002 | FDA UDI | Class II | Active |
| MyLabOne Musculoskeletal USA | 102810021 | FDA UDI | Class II | Active |
| MyLabFive | 411410 | FDA UDI | Class II | Active |
| Se3133 | 120000034 | FDA UDI | Class II | Active |
| E8-5 R10p | 411280 | FDA UDI | Class II | Active |
| MyLabOne reg. Anestesia | 102810012 | FDA UDI | Class II | Active |
| MyLabOne reg. Anestesia USA | 102810016 | FDA UDI | Class II | Active |
| MyLab40 Basic Unit | 102276004 | FDA UDI | Class II | Active |
| MyLabSix | 102642001 | FDA UDI | Class II | Active |
| C5-2 R13 | 411008 | FDA UDI | Class II | Active |
| Mylabsix Ultrasound System | K141486 | FDA 510(k) | Class II | Active |
| Mylabone Ultrasound System | K101605 | FDA 510(k) | Class II | Active |
| Imt.lab Software | K062598 | FDA 510(k) | Class II | Active |
| Mylabfive | K083882 | FDA 510(k) | Class II | Active |
| Mylab15/20 New Indications Ultrasound System | K061755 | FDA 510(k) | Class II | Active |
| Mylab40 | K070903 | FDA 510(k) | Class II | Active |
| MyLabSix Ultrasound System | K161168 | FDA 510(k) | Class II | Active |
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