CE TUV Rheinland LGA
The EC Certificate, issued by TÜV Rheinland LGA Products GmbH, certifies that Beijing BEST BIO Technical Co., Ltd. has established and maintains a full quality assurance system in accordance with Directive 93/42/EEC on Medical Devices, Annex II (excluding Section 4).
Certificate Details:
- Certificate Number: HD 2041124-1
- Manufacturer: Beijing BEST BIO Technical Co., Ltd.
Address: Room 1501, Building No.4, Wanlihuishuiyuan, Wanquanzhuang, Haidian District, 100089 Beijing, P.R. China - Scope of Certification:
- Non-sterile and sterile bone plates
- Non-sterile and sterile bone screws
- Non-sterile intramedullary nailing systems
- Non-sterile spinal systems
Certified Manufacturing Facility:
- Facility Address: Beijing BEST BIO Technical Co., Ltd., Tongzhou District, Beijing, P.R. China
- Scope: Manufacturing of certified medical devices
Certification Information:
- Report Number: 190130785 110
- Effective Date: May 19, 2021
- Expiry Date: May 26, 2024
- Issue Date: May 19, 2021
- Notified Body Identification No.: 0197 (TÜV Rheinland LGA Products GmbH)
Although the certificate officially expired on May 26, 2024, we have already applied for an extension, and TÜV Rheinland has issued an official extension letter, confirming that the certificate remains valid.
ISO 13485:2016 Quality Management System Certificate TÜV Rheinland
The ISO 13485:2016 Quality Management System Certificate, issued by TÜV Rheinland LGA Products GmbH, certifies that Beijing BEST BIO Technical Co., Ltd. has established and applies a quality management system for medical devices in compliance with EN ISO 13485:2016, EN ISO 13485:2016/AC:2018, and EN ISO 13485:2016/A11:2021 standards.
Certificate Details:
- Certificate Number: SX 2041124-1
- Certificate Holder: Beijing BEST BIO Technical Co., Ltd.
Address: Room 507, Floor 4, Building No.3, Yard 99, North Third Ring West Road, Haidian District, 100086 Beijing, P.R. China - Scope of Certification:
- Design, development, manufacturing, and distribution of:
- Bone plates
- Bone screws
- Non-sterile intramedullary nailing systems
- Non-sterile spinal systems
- Orthopedic manual surgical instruments
- Design, development, manufacturing, and distribution of:
Certified Facilities:
-
Facility No. 01
- Location: Beijing BEST BIO Technical Co., Ltd., Haidian District, Beijing
- Scope: Aspects related to administration
-
Facility No. 02
- Location: Beijing BEST BIO Technical Co., Ltd., Tongzhou District, Beijing
- Scope: Aspects related to design, development, manufacturing, and distribution
Certification Information:
- Report Number: 190157750-110
- Effective Date: September 21, 2024
- Expiry Date: September 20, 2027
- Issue Date: September 20, 2024
- Replaces Previous Certificate: SX 2041124-1 issued on September 8, 2021
Registration Certificate for Foreign Medical Device Manufacturer by Japan Government
The Registration Certificate for Foreign Medical Device Manufacturer, issued by the Ministry of Health, Labour and Welfare of Japan, certifies that Beijing BEST BIO Technical Co., Ltd. is a registered foreign medical device manufacturer under Article 23-2-4 of the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.
Certificate Details:
- Registration Number: BG10500639
- Certified Manufacturer: Beijing BEST BIO Technical Co., Ltd.
- Registered Manufacturing Facility: Beichen No. 8-3, West Yangbei Road, Beichen District, Tianjin, P.R. China
- Issuing Authority: Ministry of Health, Labour and Welfare, Japan
- Authorized Signatory: Tamura Norihisa (厚生労働大臣 田村憲久)
Validity Period:
- Effective Date: December 22, 2021
- Expiry Date: December 21, 2026
The certificate confirms that Beijing BEST BIO Technical Co., Ltd. complies with Japanese medical device regulatory requirements, allowing it to manufacture and supply medical devices in the Japanese market.