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IMEIK爱美客

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IMEIK is a Other product (Class III device), registered by 爱美客技术发展股份有限公司. Linked registrations: China 国械注准20243131967. Data as of 2026-10-23.

  • Regulatory classOther · Class III device
  • Holder爱美客技术发展股份有限公司
  • JurisdictionsCN
  • Updated2026-10-23 · v1

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

Registration and basics

IMEIK

Product
Regulatory class
Class III device
Category
Other
China · NMPA device registration
国械注准20243131967
Name on registration
医用含聚乙烯醇凝胶微球的交联透明质酸钠凝胶
Registrant
爱美客技术发展股份有限公司
First approval
Not obtained from an official source
This certificate issued
2024-09-30
Valid until
2029-09-29
Models and sizes
0.5ml、0.75ml、1.0ml、2×0.5ml、2×0.75ml、2×1.0ml、4×0.5ml、4×0.75ml、4×1.0ml
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颏部：适用于成人骨膜上层注射填充以改善轻中度的颏部后缩
Contraindications对透明质酸、聚乙烯醇或利多卡因类局部麻醉剂过敏者禁用; 孕妇、哺乳期妇女、儿童禁用; 禁止静脉注射; 颏部：颏部皮肤炎症、感染者禁止注射; 凝血机制异常的患者，或两周内接受过血栓溶解剂、抗凝血剂或血小板聚集抑制剂治疗的患者禁用; 自体免疫性疾病前期或活动期、免疫抑制剂或调节剂治疗期、活动的皮肤感染期应避免注射; 易形成瘢痕瘤或具有肥厚性疤痕体质的患者禁用; 有疱疹性湿疹病史可能发生疱疹复发的患者禁止使用
Composition透明质酸钠（微生物发酵法制备）标示含量10mg/mL；聚乙烯醇凝胶微球标示含量（干重）30mg/mL；盐酸利多卡因标示含量3mg/mL; 凝胶主要由交联透明质酸钠、聚乙烯醇凝胶微球、盐酸利多卡因、平衡盐溶液及注射用水组成
Storage原文未报告Not reported
Shelf life货架有效期为2年
Injection depth颏部：注射填充于骨膜上层（面部容量填充剂，具有一定支撑效果）
Recommended dose无法核实（摘录对不上原文或原件无法识别）Could not verify
Duration关键性临床试验FAS集，颏部，随访至第60周：关键性临床试验以第60周ACRS颏部填充有效率作为主要有效性指标：FAS集试验组为77.78%，对照组为0%，率差及95%CI为77.78%（69.94%，85.62%），置信区间下限大于30%，优效性假设成立
Adverse reactions无法核实（摘录对不上原文或原件无法识别）Could not verify
Warnings原文未报告Not reported
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. 20 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注准20243131967 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20243131967 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20243131967: certificate issued2024-09-30

Sources

5