Medical Device Registration Certificate Overview

This document is an official certificate issued by the Ministry of Health of Vietnam for the registration and circulation of a medical device classified as Type D.

1. Device Identification

• Device Name: Gingival Tissue Regeneration Material
• Trade Name: Neocirrus
• Device Type: Medical Device Type D
• Manufacturer: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., Suzhou, Jiangsu, China
• Owner of Device Registration: QUALTECH CONSULTING Co., Ltd., Ho Chi Minh City, Vietnam

2. Regulatory Basis

The certificate is issued based on the following legal documents:

• Decree No. 98/2021/ND-CP dated November 8, 2021, on medical device management
• Decree No. 07/2023/ND-CP dated March 3, 2023, amending Decree No. 98/2021/ND-CP
• Decree No. 96/2023/ND-CP dated December 30, 2023, detailing provisions of the Law on Medical Examination and Treatment

3. Purpose and Warranty

• Intended Use: The device, specifically the Augmented Gingival Matrix, is used to reinforce and expand the keratinized gingiva and deepen the vestibular sulcus.
• Warranty Service: Details provided in the attached appendix.

4. Device Details and Specifications (Appendix)

The appendix lists detailed product information including:

• Product variants identified by specific product codes (e.g., AGM-R-010010 through AGM-E-060080)
• Packaging: Each product is individually packed in Tyvek bags and boxes
• Manufacturer's full address and country of origin: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., Suzhou, Jiangsu, China

5. Distribution and Record Keeping

• The certificate is issued under a specific decision number by the Ministry of Health.
• Recipients include the device owner company, Ministry officials, customs authorities, and internal archives.

Critical Information Summary

• The device is a Type D medical device intended for gingival tissue regeneration.
• Manufactured in China by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
• Registered and distributed in Vietnam by QUALTECH CONSULTING Co., Ltd.
• Compliance with Vietnamese medical device regulations is confirmed by the Ministry of Health.
• Detailed product codes and packaging specifications are provided for traceability and regulatory compliance.

This certificate ensures the legal circulation and use of the specified medical device within Vietnam under the stated regulatory framework.