Support · Certificates
Quality and regulatory approvals
TELEMED designs and manufactures ultrasound systems under a quality management system certified to EN ISO 13485:2016. Our scanners are cleared or registered in the United States, Korea and Taiwan.
ISO 13485:2016
Certified QMS, valid until 2028
3 × FDA 510(k)
ArtUs, SmartUs, MicrUs / MicrUs Pro
Korea · Taiwan
National registrations
Quality management system
Quality Management System Certificate
- Scope
- Design, manufacture, final inspection, distribution and servicing of diagnostic ultrasound devices, ultrasound transducers, and ultrasound control and imaging software
- Certification body
- Kiwa Assurance B.V.
- Certificate
- P000510469CRT01
- Valid until
- 12 May 2028
USA · FDA 510(k) clearances
Premarket notifications cleared by the U.S. Food and Drug Administration. Each link opens the record in the FDA database.
| 510(k) | Devices | Documents |
|---|---|---|
| K211248 | ArtUs EXT-1H, ArtUs EXT-2H | FDA database |
| K163121 | SmartUs EXT-1M, SmartUs EXT-3M | FDA database · Indications for use (PDF) |
| K161968 | MicrUs EXT-1H, MicrUs Pro-L40S, MicrUs Pro-L40N, MicrUs Pro-C60S | FDA database · Indications for use (PDF) |
Show clearances for discontinued products
| 510(k) | Devices | Documents |
|---|---|---|
| K102253 | Echo Blaster 128 EXT-1Z, CEXT-1Z, INT-1Z, INT-2Z | Clearance letter (PDF) |
| K113184 | LS64 FLT-1T, FLT-2T; LS128 CEXT-1Z, EXT-1Z, EXT-2Z, INT-1Z, INT-2Z | Clearance letter (PDF) |
Korea and Taiwan
Republic of Korea
MFDS (formerly KFDA)
Registration with the Korean Ministry of Food and Drug Safety.
Taiwan
Ministry of Health and Welfare
Medical device registration in Taiwan.
Other certificates and documents on request
Other certificates and regulatory documents that are not listed on this page can be provided on request. Tell us the country and the scanner model, and we will send you the documents or check the registration status.