China Certified Medical Device Factory

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be sold and used in accordance with legal procedures, so as to decide whether to agree to their sale and use. It is divided into Chinese domestic medical device registration and overseas medical device registration. Overseas medical devices, whether class I, class II or class III, should be handled by the Beijing State Food and Drug Administration: domestic class I and class II medical devices should be handled by the local provincial or municipal food and drug administration, and class III medical devices should be handled by the State Food and drug administration. Medical device registration certificate refers to the legal ID card of medical device products. According to the regulations on the supervision and administration of medical devices, the measures for the supervision and administration of medical device production and the measures for the administration of medical device registration issued by the State Food and drug administration, the medical device products produced and / or sold in China shall meet the corresponding regulatory requirements. These requirements include: 1) The medical device manufacturer obtains the production license; 2) Medical device products have obtained registration certificate. Foosin already obtain Medical Registration in China since 2006 the latest version as following: Registration Certificate No.: lxzz 20152020252

Name of registrant	Foosin medical materials Co., Ltd
Domicile of registrant	20, Xingshan Road, Weihai Torch Hi-tech Science Park
Production address	20, Xingshan Road, Weihai Torch Hi-tech Science Park
Name of agent
Agent's domicile
Product name	Non absorbable surgical suture
Model and specification	See attached annex
Structure and composition	The product consists of suture needle and non-absorbable surgical suture.
Scope of application	It is suitable for sewing human tissue.
enclosure	Product technical requirements: lxzz 20152020252
Other contents
remarks	Original medical device registration certificate No.: lxzz 20152650252

Approved by: Shandong Provincial Drug Administration

Approval date: March 25, 2020

Valid until: March 24, 2025

(seal of approval department)

Attachment：

Product name	Nylon	Polypropylene	Polyester	Silk
USP	10-（0#-2#）	10-（0#-2#）	8-（0#-2#）	8-（0#-5#）
Suture length	30cm-299cm	45cm-299cm	45cm-299cm	30cm-299cm
Needle diameter × Chord length （0.1mm×mm）	(1.5-15)×（4.5-55）	(2-15)×（6-55）	(2-15)×（6-55）	(1.5-15)×（6-65）
Curve	1/2, 3/8, 1/4, 5/8	1/2, 3/8, 1/4, 5/8	1/2, 3/8, 1/4, 5/8	0，1/2, 3/8, 1/4, 5/8
Needle type	Round body, cutting, spatula	Round body, cutting, taper cut	Round body, cutting	Round body, cutting, taper cut
Needle quantity	0-8	0-8	0-8	0-16

Medical device registration certificate of the People's Republic of China

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