TE Air Diagnostic Ultrasound System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Full name

Diagnostic Ultrasound System

Trade Name

TE Air Diagnostic Ultrasound System

Generic Name

General-purpose ultrasound imaging system

Model / Reference

TE Air

Primary DI / UDI-DI

06903053035132

Basic UDI-DI

69449040AB050100325S

FDA Product Code

IYN

EMDN Code

Z11040106 Handheld ultrasound scanners

GMDN Term

General-purpose ultrasound imaging system

Device Class

Class IIa EUDAMED

Class II GUDID

Regulation Number

892.1550

EU market of registration

Germany

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

EUDAMED SRN

CN-MF-000014156

Authorised representative

Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

• Diagnostic Ultrasound System (Nuewa A20W)

  Class II

  FDA 510(k) K261585 Active Cleared 16 Oct 2026

• Chemistry Analyzer

  Class A

  CE/IVDR

• D-Dimer Assay Kit (Immunoturbidimetry Method)

  Class C

  CE/IVDR

• Patient monitor

  Class IIb

  CE/MDR

• Digital Radiography System

  Class IIb

  CE/MDR

• Anti-Thyrotropin Receptor Antibody (CLIA)

  Class B

  CE/IVDR

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

• What clinical settings is this ultrasound system intended for and how does it support diagnostic evaluations?

  The TE Air Diagnostic Ultrasound System is designed for non-invasive diagnostic imaging in various clinical environments, such as hospitals and outpatient care facilities. It generates real-time ultrasound images to help assess internal body structures, organs, and tissues, aiding clinicians in identifying potential abnormalities during routine or specialized evaluations.

• Is this device reusable or single-use, and what does that mean for its maintenance and sterilization?

  The TE Air is explicitly supplied as a non-reusable device, meaning it is intended for single-use only. Since it is also non-sterile, it should not be cleaned, reprocessed, or reused between patients. Clinicians must use a new unit for each patient to ensure safety and compliance with medical device guidelines.

• Can this ultrasound system be used in an MRI environment, and what safety considerations should be noted?

  No, the TE Air Diagnostic Ultrasound System is not intended for use in MRI environments. It operates within standard electromagnetic safety parameters but is not designed to withstand the strong magnetic fields or radiofrequency interference present in MRI settings, which could compromise its performance or safety.

• How do I identify the correct model and regulatory compliance of this device when ordering?

  The TE Air Diagnostic Ultrasound System is the specific model referenced in the data. It is cleared under the FDA’s 510(k) pathway (Traditional clearance, K220051) and complies with the EU Medical Device Regulation (MDR). The Basic UDI (69449040AB050100325S) ensures traceability, and the manufacturer is Shenzhen Mindray Bio-Medical Electronics Co., Ltd., distributed in Europe through Shanghai International Holding Corp. GmbH.

• What are the key differences between this device and other ultrasound systems in terms of classification and intended use?

  The TE Air is classified as a Class IIa medical device under FDA nomenclature code Z11040106, indicating it carries a moderate risk level requiring regulatory oversight. Unlike implantable or medicinal devices, it is non-sterile, non-reusable, and non-invasive, meaning it is solely for diagnostic imaging of internal structures without any medicinal or implantable functions. This distinguishes it from devices intended for surgical procedures or long-term implantation.