Medcxy

Product dossierBuilt from registrations, label text and platform-curated data

第一外科概念1st SurgiConceptSpring Thread® 春天线

Ask about this product

第一外科概念1st SurgiConcept is a Threads product (Class III device), registered by 第一外科概念1st SurgiConcept. Linked registrations: China 国械注进20253130328. Data as of 2026-10-23.

  • Regulatory classThreads · Class III device
  • Holder第一外科概念1st SurgiConcept
  • JurisdictionsCN
  • Updated2026-10-23 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

第一外科概念1st SurgiConcept

Product
Regulatory class
Class III device
Category
Threads
China · NMPA device registration
国械注进20253130328
Name on registration
面部埋植线Spring Thread® Elastic suture with cogs
Registrant
第一外科概念1st SurgiConcept
China agent
南京欧益医疗器械有限公司
First approval
Not obtained from an official source
This certificate issued
2025-07-31
Valid until
2030-07-30
Models and sizes
FL 6-300×6
Checked against official page
2026-10-23

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

AttributeChina label
Indications年龄限制：适用人群为25-70周岁。; 面部/鼻唇沟皱纹：适用于植入面部浅肌筋膜组织，以纠正中度鼻唇沟皱纹。
Contraindications感染。; 精神疾病的患者。; 对埋植线表面材料过敏。; 皮肤过薄而导致埋植线可视或可被触及。; 孕妇、儿童、系统性疾病（肝、脑、心血管疾病）。; 面部软组织过多。; 严重下垂。
Composition该产品由聚对苯二甲酸乙二醇酯（PET）制成的纤维芯和聚二甲基硅氧烷外层（带外层锯齿）组成，为多股未染色锯齿线。
Storage原文未报告Not reported
Shelf life货架有效期5年。
Injection depthFL型号/面部：推荐用针：特定针（FL型号用BASE 13）、开槽或带眼的无菌手术（直径≤0.8mm）。; 面部/鼻唇沟皱纹：植入面部浅肌筋膜组织。
Recommended dose面部/鼻唇沟皱纹：植入数量不应超过6根。
Duration原文未报告Not reported
Adverse reactions说明书不良反应：矫正效果不对称。; 说明书不良反应：短暂性疼痛。; 说明书不良反应：血瘀、水肿或血肿。; 境外不良事件报告：境外不良事件报告总数为82条，包括感染、过敏、皮下肿块、纤维化、线头露出、肉芽肿、炎症等。; 说明书不良反应：对神经或血管周围的解剖结构造成损伤。; 说明书不良反应：炎症反应。; 说明书不良反应：局部感染。; 说明书不良反应：植入层次过浅导致产品的痕迹可见。
Warnings请勿在包装或产品受损的情况下使用本产品。; 开封前检查包装完整性；铝箔袋为非无菌，纸塑袋为无菌屏障，注意无菌操作；包装完整方可视为无菌产品。; 请勿使用已过期的产品。; 一次性器械，请勿重复使用；重复使用可能因消毒缺陷对患者造成危险或功能问题。; 仅限接受过面部埋植线应用操作相关培训的医师。; 年龄限制：适用于25-70周岁人群。; 医师应当告知患者所涉植入为永久性植入。; 该埋植线植入人体后不可被X射线检测到。
preparation不适用N/A
storage after preparation不适用N/A

Each cell is extracted from that jurisdiction's label; click the number for the original passage. “—” means nothing has been extracted for it yet, not that the label is silent. 34 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20253130328 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20253130328 valid until

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

Cross findings · Price observations

Sign in to see findings and prices

Findings and prices stay out of indexable pages.

Sign in to view

Recent changes

1
  • 国械注进20253130328: certificate issued2025-07-31

Sources

6