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Aisumei PCL FillerAisumei PCL Microsphere Facial Filler (Domestic)

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Aisumei PCL Filler is a PCL product (Class III device), registered by 山东采采医疗科技有限公司. Linked registrations: China 国械注准20243131626. Data as of 2026-11-02.

  • Regulatory classPCL · Class III device
  • Holder山东采采医疗科技有限公司
  • JurisdictionsCN
  • Updated2026-11-02 · v1

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

Registration and basics

Aisumei PCL Filler

Product
Regulatory class
Class III device
Category
PCL
China · NMPA device registration
国械注准20243131626
Name on registration
注射用聚己内酯微球面部填充剂
Registrant
山东采采医疗科技有限公司
First approval
Not obtained from an official source
This certificate issued
2024-08-27
Valid until
2029-08-26
Models and sizes
型号：Ⅰ型 规格：0.5ml/支、1.0ml/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下颌：适用于注射到皮下组织，填充下颌区域，以改善轻度至中度下颌后缩患者的下颌轮廓
Contraindications禁用于凝血机制异常的患者，或在两周内接受过血栓溶解剂、抗凝剂或血小板凝结抑制剂治疗的患者; 禁用于有形成瘢痕疙瘩、增生性疤痕倾向或任何其他愈合障碍的患者; 禁用于有过敏性病史的患者与多发性严重过敏史的患者; 本品不得超适用范围使用; 禁用于已知对产品成分有过敏反应的患者; 禁止与其他产品混合使用，包括注射永久性填充剂的部位，6个月内曾经使用过非永久性填充剂的部位; 皮肤病、炎症、感染或类似情况的部位及其邻近部位禁止使用; 禁用于有活动性自身免疫疾病或病史（如系统性红斑狼疮、类风湿关节炎、硬皮病、皮肌炎等）、患有卟啉症的患者
Composition凝胶颗粒悬液主要由聚己内酯微球、甘油、羧甲纤维素、磷酸盐缓冲体系组成；聚己内酯微球质量百分比为30%
Storage原文未报告Not reported
Shelf life货架有效期2年
Injection depth注射针材质为304不锈钢，规格为27G; 下颌：注射到皮下组织
Recommended dose下颌：单次注射剂量不超过2.0 mL
Duration原文未报告Not reported
Adverse reactions原文未报告Not reported
Warnings怀孕、哺乳期妇女以及21岁以下人群不得使用; 本品与其他药物、器械的联合应用研究未有报道; 治疗后约24小时内，在注射后的肿胀和发红消退之前，注射部位不应暴露在强热（例如日光浴）或极度寒冷的环境下，也不可接受皮肤护理（例如按摩、面膜护理等）; 接受本品治疗后如马上再接受激光治疗、化学脱皮或其它可引起真皮活动性反应的类似治疗，理论上会有引发注射部位炎症反应的风险；在上述治疗后皮肤未彻底愈合前接受本品治疗也有这种潜在风险; 本品仅验证了单次注射的安全性及有效性，多次注射的安全性有效性未经验证，长期使用的风险未知；本品仅限单次注射使用，不得进行多次反复注射，不能用于补充注射
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. 24 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注准20243131626 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20243131626 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20243131626: certificate issued2024-08-27

Sources

6