Resona I9 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 24 Oct 2026.

Full name

Diagnostic Ultrasound System

Model / Reference

Resona I9, Imagyn I9, Nuewa I9, Hepatus 9, TEX series, Crius TEX20, M9/M9T/M9CV/M9GI/M8/M8CV/M8T/M8GI/M10/M10CV/M10S/M10T/M10 Exp/M10 Pro/Anesus M10/Crius M10/ Emerus M10/MVP /M11/M11CV/M11S/M11T/M11 Exp/M11 Pro/Anesus M11/Crius M11/Operus M11/Monet/M9 Premium, M8GI, Resona I10, Resona I10K, Resona R7, Nuewa R7, Imagyn R7, Eagus R7, Nuewa R Xgen, Ophthus 9 Pro, Eagus I8, Z5, Z5T, Z5BW, Z50, Z50T, Z50BW, Z50S, Z50W, Z50 Pro, Z50 Expert, Z70, Z70S, Z70 Pro, Z70 Expert, MX7, Ana, Resona I10 Super, TE7/TE7T /TE7S /TE7 Pro/TE7 Super /TE5 /TE5T /TE5S /TE5 Pro/TE5 Super, TE10S, Resona R9, Nuewa R9, Eagus R9, Imagyn R9, Imagyn R9 Elite, Emerus ME7P, Eagus R Elite, Hepatus 8 P, ME7 Pro, DP-60/Z6/ Z6T/ Z6S/ Z6W/ Z6 Pro/ Z6 Expert/ Z8/ Z8S/ Z8 Pro/ Z8 Expert/ Z60/ Z60T/ Z60S/ Z60W/ Z60 Pro/ Z60 Expert/ Z80/ Z80S/ Z80 Pro/ Z80 Expert, Z6S, Recho R9W, Recho R7T, Nuewa A20W, Nuewa A Swan, Resona Y xv, Resona R7Q, Resona R7T, Consona N9, Consona N8, Consona N7, Consona N6, Resona N9 Elite, Consona VX, Emerus TEX20, DC-58/ DC-55/ DC-51/ DC-52/ DC-56/ DC-57/ DC-59/ DC-58S/ DC-50/ DC-50T/ DC-50S/ DC-50 Exp/ DC-59S/ DC-59 Exp/ DC-59 Pro/ DC-59T, DC-50T, Z80 Expert, Resona 8Elite, MX8 Exp, Crius ME7P, Z8 Expert, Recho I7, Nuewa R MV, Resona A10S, Resona A20G, MX3, MX3 BW, Consona OX, Consona N6 Plus, Ophthus 10T, Nuewa A20 Exp, TE9, DC-59 Exp, TE8S, Zeus8, Consona N5, Consona N3, Nuewa A Elite, DC-32, DC-30, DC-28, DC-26, DC-25, DC-20, DC-20S, DC-20 Exp, DC-20 Pro, DC-21, DC-22, DC-30S, DC-30 Exp, DC-32S, DC-32 Exp, DC-32 Pro, DC-Bela, Consona N5P, Anesus TE7, MX5T, DC-60, DC-60 Pro, DC-60 Exp, DC-60S, DC-65, DC-65 Pro, DC-65 Exp, DC-65S, DC-65T, DC-61, DC-62, DC-63, DC-69, DC-69S, DC-69 Exp, DC-69 Pro, DC-69T, DC-66

Primary DI / UDI-DI

06903053040433, 06903053003858, 06936415978242, 06903053109499, 06936415999322, 06903053164603, 06903053044165, 06936415973315, 06936415926762, 06903053109628, 06903053001540, 06936415998776, 06936415926670, 06936415999636, 06903053164610, 06936415974176, 06936415978426, 06903053040976, 06936415973377, 06903053063920, 06903053000055, 06936415999575, 06936415999599, 06903053013161, 06903053012706, 06903053003872, 06936415979058, 06903053001847, 06936415971113, 06936415926793, 06936415926632, 06936415978457, 06903053044318, 06936415998844, 06903053045339, 06903053077200, 06903053012881, 06903053012430, 06903053048491, 06903053063890, 06903053001779, 06903053004800, 06903053001663, 06936415926847, 06903053082020, 06903053064057, 06936415972110, 06903053082044, 06903053049344, 06903053077026, 06903053004886

Basic UDI-DI

69449040AB050100265X, 69449040AB0501002965, 69449040AB050100045M, 69449040AB0501004869, 69449040AB050100335U, 69449040AB050100165U, 69449040AB0501001962, 69449040AB050100035K, 69449040AB050100015F, 69449040AB050100155S, 69449040AB050100445Z, 69449040AB0501004767, 69449040AB050100305N, 69449040AB050100095X, 69449040AB050100435X, 69449040AB0501004563, 69449040AB0501004665, 69449040AB050100115J, 69449040AB050100085V

EMDN Code

Z11040104, Z11040103

Device Class

Class IIa

EU market of registration

Germany

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 are the key differences between the Resona I9, Imagyn I9, and Nuewa I9 models of this ultrasound system?

  The Resona I9, Imagyn I9, and Nuewa I9 are distinct models of the same Diagnostic Ultrasound System, but the data provided does not specify functional or technical distinctions between them. All three models are non-sterile, non-reusable, and intended for single-use clinical imaging. They share the same nomenclature code (Z11040104) and regulatory compliance (FDA 510K and MDR), so their primary purpose remains real-time ultrasound imaging of internal structures. If specific features or capabilities differ, they are not detailed in the provided data.

• Is this ultrasound system safe for use in patients who have metal implants or are undergoing MRI scans?

  The Resona I9 Diagnostic Ultrasound System is explicitly **not** labeled as MRI-safe or designed for use in patients with metal implants. Since it is an active device, it should not be used in environments where MRI compatibility is required, and its safety in proximity to metal implants is not addressed in the provided data. Always verify compatibility with the patient’s specific medical history and facility protocols.

• How should this device be stored, and what are the implications of its non-sterile and single-use nature?

  The Resona I9 Diagnostic Ultrasound System is **non-sterile** and intended for **single-use only**, meaning it cannot be reused or reprocessed. Storage should follow manufacturer guidelines (not provided here) to maintain functionality, but it must be treated as a non-sterile device—suitable only for diagnostic imaging in controlled clinical settings. Sterile accessories or probes (if applicable) would require separate handling and validation.

• Does this device contain any latex or animal-derived materials, and what are the implications for patients with allergies?

  The Resona I9 Diagnostic Ultrasound System is explicitly labeled as **latex-free** and **not containing animal-derived substances**. This makes it a safer option for patients with latex allergies or sensitivities to animal proteins. However, always confirm with the manufacturer if additional components (e.g., cables, probes) are used in conjunction with the system, as those may vary.

• What regulatory pathways does this device follow, and how does that affect its availability in different markets?

  This device is authorized under **FDA 510K** (U.S.) and **MDR (Medical Device Regulation)** compliance in the EU, indicating it meets the necessary standards for market authorization in those regions. The **Basic UDI (69449040AB050100265X)** ensures traceability, and distribution in Europe is handled by **Shanghai International Holding Corp. GmbH (Europe)**. Availability in other markets depends on local regulatory approvals, which are not specified here.