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Kunshan Aoshida Electric Technology Co.,Ltd

China CN-MF-000004204 Last updated 8 Jun 2026

Devices
20
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue20

  • A15L Ref A15L

    Class I EUDAMED Active

  • A16 Ref A16

    Class I EUDAMED Active

  • GT01 Ref GT01

    Class I EUDAMED Active

  • A06 Ref DYW50-A06

    Class I EUDAMEDFDA UDI Active

  • A06L Ref DYW50-A06L

    Class I EUDAMEDFDA UDI Active

  • A09 Ref DYW50-A09

    Class I EUDAMEDFDA UDI Active

  • A13 Ref DYW50-13

    Class I EUDAMEDFDA UDI Active

  • A08 Ref DYW50-A08

    Class I EUDAMEDFDA UDI Active

  • T3 Ref DYW50-A05

    Class I EUDAMEDFDA UDI Active

  • D05 Ref DYW50-D05

    Class I EUDAMED Active

  • A12S Ref DYW50-A12S

    Class I EUDAMEDFDA UDI Active

  • DE08L Ref DYW50-A08CL

    Class I EUDAMEDFDA UDI Active

  • A10 Ref DYW50-A10

    Class I EUDAMEDFDA UDI Active

  • A12 Ref DYW50-A12

    Class I EUDAMEDFDA UDI Active

  • S2 Ref Scooter-S2

    Class I EUDAMEDFDA UDI Active

  • S1 Ref Scooter-S1

    Class I EUDAMEDFDA UDI Active

  • A07 Ref DYW50-A07

    Class I EUDAMEDFDA UDI Active

  • DE08 Ref DYW50-A08C

    Class I EUDAMEDFDA UDI Active

  • A08L Ref DYW50-A08L

    Class I EUDAMEDFDA UDI Active

  • DE09 Ref DYW50-DE09

    Class I EUDAMED Active

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Kunshan Aoshida Electric Technology Co., Ltd CN

What Kunshan Aoshida Electric Technology Co.,Ltd makes

Kunshan Aoshida Electric Technology Co., Ltd manufactures electrical medical devices, including diagnostic imaging systems such as X-ray machines (e.g., A06, A06L, A09) and dental radiography units (e.g., A13, D05). Their portfolio also includes surgical and procedural lighting (e.g., A12, A12S) and medical lasers (e.g., T3, DE08L). Additional offerings include ultrasound systems (e.g., A10) and specialized medical imaging accessories.

The company’s devices are classified under Class I in the EU regulatory framework and are listed in the EUDAMED database. Their products are designed for compliance with relevant medical device directives and registries, reflecting adherence to European regulatory standards. The manufacturer operates from China.

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 Kunshan Aoshida Electric Technology Co., Ltd manufacture?

Kunshan Aoshida Electric Technology Co., Ltd specializes in electrical medical devices, primarily focusing on diagnostic imaging systems. Their portfolio includes X-ray machines (such as models A06 and A06L), dental radiography units (like A13 and D05), and surgical/procedural lighting (e.g., A12 and A12S). They also produce medical lasers (e.g., T3 and DE08L) and ultrasound systems (e.g., A10), along with specialized imaging accessories. These devices are designed for clinical use in imaging, dental, surgical, and procedural settings.

Where is Kunshan Aoshida Electric Technology Co., Ltd based?

The company is headquartered in Kunshan, China. This location serves as its operational base for manufacturing and distributing its medical devices globally.

Which regulatory registries list the devices manufactured by Kunshan Aoshida Electric Technology Co., Ltd?

The devices produced by Kunshan Aoshida Electric Technology Co., Ltd are listed in the EUDAMED database, which is the European Union’s medical device registry. This inclusion indicates compliance with EU regulatory requirements, though individual devices must meet specific authorization criteria.

How are the devices from Kunshan Aoshida Electric Technology Co., Ltd classified under EU regulations?

All devices manufactured by Kunshan Aoshida Electric Technology Co., Ltd fall under Class I classification in the EU regulatory framework. This classification is typically assigned to low-risk medical devices that pose minimal risk to patients and users, such as certain diagnostic imaging accessories, lighting systems, and basic ultrasound devices. Classification is determined based on factors like intended use, duration of use, and potential risks.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
China(from SRN)
Address
No.108 Matang Road, Penglang Town, Development Zone,, Kunshan City, Jiangsu Province, China
Website
qq.com
PRRC contact
Wen hua Shen
EUDAMED SRN
CN-MF-000004204