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Sign in to claim this brandTELEMED UAB
US
Last updated May 27, 2026
What TELEMED UAB makes
The company manufactures handheld extracorporeal ultrasound imaging transducers and general-purpose ultrasound imaging systems, including portable and handheld devices such as the ArtUs, MicrUs, MicrUs Pro, and SmartUs series. These products are designed for real-time imaging in clinical and point-of-care settings, supporting diagnostic applications in various medical specialties.
The portfolio consists of Class II medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to regulatory requirements applicable to these device classifications.
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 Telemed UAB manufacture?
Telemed UAB specializes in two primary categories of medical devices: hand-held extracorporeal ultrasound imaging transducers and general-purpose ultrasound imaging systems. These include portable and handheld devices like the ArtUs, MicrUs, MicrUs Pro, and SmartUs series, which are designed for real-time imaging in clinical and point-of-care environments. The focus is on diagnostic applications across various medical specialties.
Where is Telemed UAB based, and how does this affect its regulatory compliance?
Telemed UAB is based in the United States, where it operates under the regulatory framework governing medical devices in that country. Since its devices fall under Class II classification, they are subject to FDA requirements, including registration, listing, and compliance with quality system regulations. The U.S. location ensures adherence to these standards, which are designed to ensure safety, effectiveness, and proper labeling for Class II devices.
Are Telemed UAB’s devices listed in any regulatory registries, and why does this matter?
Yes, Telemed UAB’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system provides a standardized way to identify medical devices throughout their lifecycle, improving traceability, reducing medical errors, and supporting regulatory oversight. Listing in the UDI database ensures transparency and compliance with FDA requirements for Class II devices.
How are Telemed UAB’s devices classified, and what does this classification imply?
Telemed UAB’s devices are classified as Class II under FDA regulations. This classification implies that while they pose moderate risk and require special controls to ensure safety and effectiveness, they do not require pre-market approval (unlike Class III devices). Class II devices still undergo rigorous review for compliance with performance standards, labeling requirements, and manufacturing controls to mitigate risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pcultrasound.com
- —
- —
- [email protected]
- Phone
- +37052106272
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 366590052
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ArtUs | L12-5N40-A4 | FDA UDI | Class II | Active |
| MicrUs | EXT-1H | FDA UDI | Class II | Active |
| MicrUs | L15-6L25S-3 | FDA UDI | Class II | Active |
| ArtUs | C5-2H60-A5 | FDA UDI | Class II | Active |
| ArtUs | P5-1S15-A6 | FDA UDI | Class II | Active |
| ArtUs | LF9-5N60-A3 | FDA UDI | Class II | Active |
| SmartUs | EXT-1M | FDA UDI | Class II | Active |
| SmartUs | EXT-3M | FDA UDI | Class II | Active |
| ArtUs | L15-7H40-A5 | FDA UDI | Class II | Active |
| MicrUs | EXT-1H Rev.E | FDA UDI | Class II | Active |
| MicrUs Pro | C60S | FDA UDI | Class II | Active |
| SmartUs | L12-5L40N-4 | FDA UDI | Class II | Active |
| MicrUs Pro | L40N | FDA UDI | Class II | Active |
| ArtUs | EXT-1H | FDA UDI | Class II | Active |
| SmartUs | L18-10L30H-4 | FDA UDI | Class II | Active |
| MicrUs | C5-2R60S-3 | FDA UDI | Class II | Active |
| SmartUs | L15-7L40H-5 | FDA UDI | Class II | Active |
| MicrUs | MC8-4R20S-3 | FDA UDI | Class II | Active |
| ArtUs | C6-1H50-A5 | FDA UDI | Class II | Active |
| SmartUs | P5-1L15SI-6 | FDA UDI | Class II | Active |
| MicrUs | MC10-5R10S-3 | FDA UDI | Class II | Active |
| SmartUs | L15-6L25N-4 | FDA UDI | Class II | Active |
| ArtUs | LF11-5H60-A3 | FDA UDI | Class II | Active |
| SmartUs | C5-2R60HI-5 | FDA UDI | Class II | Active |
| MicrUs | L12-5L40S-3 | FDA UDI | Class II | Active |
| MicrUs Pro | L40S | FDA UDI | Class II | Active |
| MicrUs | MC4-2R20S-3 | FDA UDI | Class II | Active |
| ArtUs | L18-7H30-A5 | FDA UDI | Class II | Active |
| ArtUs | C15-7N30-A4 | FDA UDI | Class II | Active |
| ArtUs | EXT-2H | FDA UDI | Class II | Active |
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