MIRARI Cold Plasma System Officially Granted Medical Device Circulation Registration Certificate By The Ministry Of Health – Achieving Class C Classification

The Infrastructure and Medical Devices Administration (Ministry of Health of Vietnam) has officially issued the Medical Device Circulation Registration Certificate for the Mirari Cold Plasma System, classified as a Class C Medical Device (TBYT Loai C). This represents a significant legal and quality milestone, affirming the device’s safety, clinical efficacy, and compliance with international medical standards for distribution and clinical use in Vietnam.

1. A Major Regulatory Milestone: Classified as a Class C Medical Device

On July 31, 2026, the Infrastructure and Medical Devices Administration of the Ministry of Health issued Circulation Registration Certificate No. 2603022ĐKLH/HTTB-ĐKKD (pursuant to Decision No. 156/QĐ-HTTB) for the Cold plasma device for supporting the treatment of skin and soft tissue lesions and pain relief, with MIRARI DOCTOR VIETNAM COMPANY LIMITED holding the circulation registration certificate and warranty responsibility.

In Vietnam, Class C medical devices fall under the medium-to-high risk category, subject to rigorous technical documentation review, clinical safety evaluations, and strict manufacturing compliance verified by the Ministry of Health. Attaining Class C circulation approval validates the product’s high safety profile, therapeutic effectiveness, and complete regulatory compliance.

2. U.S. Origin & Advanced Cold Plasma Technology

The Mirari Cold Plasma System (Model: GV-M2-01) is developed and manufactured by leading healthcare technology entities in the United States:

• Medical Device Owner: General Vibronics, Inc. (1615 E. Warner Road, Suite 4, Tempe, AZ 85284, UNITED STATES).
• Manufacturing Facility: Express Manufacturing, Incorporated (3519 West Warner Avenue, Santa Ana, California, 92704, UNITED STATES).
• Circulation License Holder & Service Center: MIRARI DOCTOR VIETNAM COMPANY LIMITED (130 Duy Tan, Cau Kieu Ward, Ho Chi Minh City).

The device is 100% brand-new, engineered and manufactured in the United States under strict international quality control systems prior to import and official release in Vietnam.

3. Clinical Indications & Medical Benefits

According to the official medical indications approved by the Ministry of Health, the Mirari Cold Plasma System (GV-M2-01) is indicated for:

• Treatment of skin & soft tissue lesions: Indicated to provide tissue coagulation, skin lesion removal, and thermal heating to elevate tissue temperature in selective medical conditions.
• Pain relief & muscle relaxation: Provides temporary pain relief and reduces muscle spasms.
• Enhanced localized circulation: Promotes local blood circulation, supporting faster tissue regeneration and recovery.

Leveraging non-invasive cold atmospheric plasma technology, the device offers a gentle, safe, and effective therapeutic experience, helping hospitals, clinics, and medical centers optimize treatment efficacy.

“Attaining Class C Medical Device Registration from the Ministry of Health is a testament to the safety, advanced technology, and clinical value of the Mirari Cold Plasma System. We are committed to empowering healthcare practitioners across Vietnam with state-of-the-art U.S. technology to improve patient care and treatment outcomes.” — Representative of MIRARI DOCTOR VIETNAM CO., LTD.

4. Regulatory & Product Specifications at a Glance

Device Name	Cold plasma device for supporting the treatment of skin and soft tissue lesions and pain relief
Trade Name / Model	Mirari Cold Plasma System (Model Code: GV-M2-01)
Circulation Certificate No.	2603022ĐKLH/HTTB-ĐKKD
Decision Number	156/QĐ-HTTB (Issued: July 31, 2026)
Issuing Authority	Infrastructure and Medical Devices Administration – Ministry of Health of Vietnam
Classification	Class C Medical Device (TBYT Loai C)
Device Owner	General Vibronics, Inc. (1615 E. Warner Road, Suite 4, Tempe, AZ 85284, USA)
Manufacturer	Express Manufacturing, Incorporated (Santa Ana, California, USA)
License Holder & Warranty	MIRARI DOCTOR VIETNAM COMPANY LIMITED Address: 130 Duy Tan, Cau Kieu Ward, Ho Chi Minh City, Vietnam