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Jinbo Biology (Sistermer)Sistermer III Collagen Injectable Solution

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Jinbo Biology (Sistermer) is a Collagen product (Class III device), registered by 山西锦波生物医药股份有限公司. Linked registrations: China 国械注准20233131245. Data as of 2026-10-23.

  • Regulatory classCollagen · Class III device
  • Holder山西锦波生物医药股份有限公司
  • JurisdictionsCN
  • Updated2026-10-23 · v1

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

Registration and basics

Jinbo Biology (Sistermer)

Product
Regulatory class
Class III device
Category
Collagen
China · NMPA device registration
国械注准20233131245
Name on registration
注射用重组Ⅲ型人源化胶原蛋白溶液
Registrant
山西锦波生物医药股份有限公司
First approval
Not obtained from an official source
This certificate issued
2023-08-28
Valid until
2028-08-27
Models and sizes
型号：2mg/ml规格：0.5ml/支、1.0ml/支、1.5ml/支、2.0ml/支、2.5ml/支、3.0ml/支、3.5ml/支、4.0ml/支、4.5ml/支、5.0ml/支、6.0ml/支
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额部皱纹：适用于面部真皮组织填充，以纠正额部动力性皱纹（包括眉间纹、额头纹和鱼尾纹）
Contraindications预期注射部位存在感染性、化脓性伤口者禁止注射; 不适用于严重自身免疫系统疾病患者; 孕妇及哺乳者：孕妇及哺乳者安全性尚未评估; 不适用于严重过敏体质者，包括但不限于对重组蛋白、胶原蛋白过敏的患者；对首次注射过敏者，严禁再次注射
Composition由重组Ⅲ型人源化胶原蛋白（A型）和0.9%的生理盐水组成，胶原蛋白浓度2mg/ml
Storage保存温度为2~8℃，请勿置于冷冻库和冰箱出风口处，避免冷冻
Shelf life货架有效期2年
Injection depth通过注射方式植入人体皮肤真皮组织
Recommended dose原文未报告Not reported
Duration原文未报告Not reported
Adverse reactions本次临床试验（随机入组152例，观察期5个月）：注射后局部针刺会有少量红肿、瘙痒和淤青，主要发生在注射当天，基本在7天内消退; 本次临床试验（随机入组152例，观察期5个月）：试验组和对照组均无注射后感染、结节、肉芽肿和瘢痕副反应
Warnings仅限在国家正式批准的医疗机构中，由具有相关专业医师资格、经生产厂家或其委托或指定机构专业培训并获得培训合格证书的人员，严格按照产品使用说明书使用; 使用时须避免将本产品直接注射入血管中，以免胶原蛋白造成血小板凝集而导致局部血管栓塞; 建议单独使用，禁止与蛋白失活剂同时使用；如需联合用药，应向医师咨询; 注射后可能出现瘙痒、红肿、疼痛、硬结等局部反应，若24小时后依然存在，请向医生咨询; 本产品忌口服，应放在儿童接触不到的地方; 使用抗凝药物者（如阿司匹林或非类固醇抗发炎药物等）使用本产品时会增加注射部位的出血程度; 超出产品有效期或包装出现破损时请勿使用
preparation原文未报告Not reported
storage after preparation原文未报告Not reported

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. 22 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注准20233131245 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20233131245 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.

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Recent changes

1
  • 国械注准20233131245: certificate issued2023-08-28

Sources

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