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Changchun AIK Medical Devices Co., Ltd.

US

Last updated September 17, 2026

Part of Changchun AiK Medical Devices Co., Ltd.

What Changchun AIK Medical Devices Co., Ltd. makes

The company manufactures single-use acupuncture needles, including sterile variants and specialized types such as KMA and BON Spring Needles, designed for one-time medical use in acupuncture procedures.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

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 Changchun AIK Medical Devices Co., Ltd. manufacture?

Changchun AIK Medical Devices Co., Ltd. specializes in single-use acupuncture needles. These include standard sterile acupuncture needles as well as specialized variants like KMA needles and BON Spring Needles, all designed for one-time medical use in acupuncture treatments. The focus is exclusively on this category of devices.

Where is Changchun AIK Medical Devices Co., Ltd. based?

The company is based in the United States. This location is relevant for regulatory oversight, manufacturing standards, and compliance with U.S. medical device regulations.

Which regulatory registries list the devices manufactured by Changchun AIK Medical Devices Co., Ltd.?

The devices produced by Changchun AIK Medical Devices Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements.

How are the devices manufactured by Changchun AIK Medical Devices Co., Ltd. classified under FDA regulations?

The acupuncture needles produced by Changchun AIK Medical Devices Co., Ltd. fall under Class II classification according to FDA regulations. This classification is based on the level of risk associated with the device, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.

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

Information

Country
US
Address
—
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
543439762

Catalogue (424)

Page 1 of 9
DeviceModel / ReferenceRegistriesClassStatus
Sterile Acupuncture Needles For Single Use 0.22*60
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.22*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*30
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*30
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*15
FDA UDI
Class IIActive
Kma 0.30*50mm
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*75
FDA UDI
Class IIActive
BON Spring Needles 0.25*50mm
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*60
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*60
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*40
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*60
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*60
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.22*30
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.22*30
FDA UDI
Class IIActive
Kma 0.25*40mm
FDA UDI
Class IIActive
BON Spring Needles 0.30*60mm
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.20*40
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.22*50
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*50
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*30
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*25
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.16*30
FDA UDI
Class IIActive
BON Spring Needles 0.20*30mm
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.16*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.40*30
FDA UDI
Class IIActive
Kma 0.20*50mm
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*13
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*15
FDA UDI
Class IIActive
BON Spring Needles 0.30*40mm
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*40
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*30
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.35*30
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.16*25
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.30*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.20*25
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.25*15
FDA UDI
Class IIActive
Sterile Acupuncture Needles For Single Use 0.18*30
FDA UDI
Class IIActive

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