Medcxy

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

Jinbo Biology (Sistermer)Sistermer Pure III Collagen Fiber (Lyophilized)

Ask about this product

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20213130488. Data as of 2026-10-29.

  • Regulatory classCollagen · Class III device
  • Holder山西锦波生物医药股份有限公司
  • JurisdictionsCN
  • Updated2026-10-29 · 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20213130488
Name on registration
重组Ⅲ型人源化胶原蛋白冻干纤维
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
2026-06-23
Valid until
2031-06-27
Models and sizes
2 mg/瓶、4 mg/瓶、6 mg/瓶、8 mg/瓶、10 mg/瓶、12 mg/瓶、16 mg/瓶、20 mg/瓶、24 mg/瓶
Checked against official page
2026-10-29

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

No data yet

Registration timeline

  1. CN

    国械注准20213130488 change

    官网变更：1. “型号、规格”由“4mg/瓶”变更为“2mg/瓶、4mg/瓶、6mg/瓶、8mg/瓶、10mg/瓶”。2. 产品技术要求变更详见产品技术要求变化对比表。

  2. CN

    国械注准20213130488 change

    官网变更：生产地址由山西综改示范区太原唐槐园区锦波街18号;变更为：山西省太原市小店区化章街88号、山西综改示范区太原唐槐园区锦波街18号。

  3. CN

    国械注准20213130488 change

    官网变更：一、结构及组成由“该产品为白色海绵状固体，由重组Ⅲ型人源化胶原蛋白组成。玻璃瓶包装，一次性使用，无菌过程生产。货架有效期18个月。该产品使用时用无菌生理盐水溶解”变更为“该产品为白色海绵状固体，由重组Ⅲ型人源化胶原蛋白组成。玻璃瓶包装，一次性使用，无菌过程生产。货架有效…

  4. CN

    国械注准20213130488 this certificate issued

    Issue date of this certificate, not the first approval

  5. CN

    国械注准20213130488 change

    延续或变更注册获批（受理号 CQY2600080；2026年06月25日医疗器械批准证明文件送达信息）

  6. CN

    国械注准20213130488 change

    官方页记录已更新（旧系统 2026-10-18 抓取 NMPA 数据查询）：批准日期 2021-06-28 → 2026-06-23；有效期至 2026-06-27 → 2031-06-27。快照（2026-06）里的旧值：批准日期 2021-06-28，有效期至 2026-06…

  7. CN

    国械注准20213130488 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

5
  • 国械注准20213130488: certificate issued2026-06-23
  • 国械注准20213130488: 延续或变更注册获批（受理号 CQY2600080；2026年06月25日医疗器械批准证明文件送达信息）2026-06-23
  • 国械注准20213130488: 官方页记录已更新（旧系统 2026-10-18 抓取 NMPA 数据查询）：批准日期 2021-06-28 → 2026-06-23；有效期至 2026-06-…2026-06-23
  • 国械注准20213130488: 官网变更：一、结构及组成由“该产品为白色海绵状固体，由重组Ⅲ型人源化胶原蛋白组成。玻璃瓶包装，一次性使用，无菌过程生产。货架有效期18个月。该产品使用时用无菌生…2024-11-04
  • 国械注准20213130488: 官网变更：生产地址由山西综改示范区太原唐槐园区锦波街18号;变更为：山西省太原市小店区化章街88号、山西综改示范区太原唐槐园区锦波街18号。2023-03-27

Sources

1