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摩漾注射用羟基磷酸钙微球面部填充剂

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摩漾 is a CaHA product (Class III device), registered by Shanghai Moyom Biotechnology Co., Ltd.. Linked registrations: China 国械注准20253130390. Data as of 2026-10-23.

  • Regulatory classCaHA · Class III device
  • HolderShanghai Moyom Biotechnology Co., Ltd.
  • JurisdictionsCN
  • Updated2026-10-23 · v1

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

Registration and basics

摩漾

Product
Regulatory class
Class III device
Category
CaHA
China · NMPA device registration
国械注准20253130390
Name on registration
注射用羟基磷酸钙微球面部填充剂
Registrant
上海摩漾生物科技有限公司
First approval
Not obtained from an official source
This certificate issued
2025-02-17
Valid until
2030-02-16
Models and sizes
见附页。
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鼻唇沟：用于鼻唇沟部位皮下层注射，以纠正中重度鼻唇沟皱纹
Contraindications请勿将本品注射入患有急性或慢性皮肤疾病（炎症或感染）的皮肤组织周围; 请勿将本品使用于有凝血或肝功能障碍或正在使用抗凝剂的患者; 请勿将本品使用于对本产品中所有成分有过敏史的患者; 特殊人群：请勿将本品用于怀孕、备孕、哺乳期间和18岁以下患者; 本产品不适用于全身性疾病患者，不得用于活动性脓毒症或感染自身免疫性疾病（或有自身免疫性疾病史）的患者; 请勿将本品使用于增生性疤痕或疤痕体质的患者
Composition产品由羟基磷酸钙、羧甲基纤维素钠、甘油、水组成
Storage原文未报告Not reported
Shelf life货架有效期为3年
Injection depth鼻唇沟：注射至鼻唇沟部位皮下层，以纠正中重度鼻唇沟皱纹
Recommended dose原文未报告Not reported
Duration鼻唇沟皱纹纠正，随机对照临床试验，随访12个月：FAS集分析：试验组治疗后12个月皱纹纠正的有效率为39.36%，对照组为22.34%，两组率差17.02%（双侧95%CI 4.04%～30.00%），非劣效假设检验成立；评价时点为治疗后12个月
Adverse reactions随机对照临床试验：本研究中试验组与对照组在不良事件（AE）发生率方面组间比较无统计学差异
Warnings严格遵守无菌操作原则，注射前需对注射部位进行消毒处理; 特殊人群：对接受免疫力抑制药物或全身类固醇治疗的患者，或有结缔组织疾病、出血性疾病或严重营养不良的患者，本产品的安全性、有效性暂无验证; 本产品进行多次注射的安全性未经验证; 本产品切勿注射入血管; 本产品使用前无需进行皮试; 使用过程中如有不适请立即停止使用本品，并进行临床观察判断患者状况; 请勿与其他产品复配使用; 治疗前要充分调查患者病史，注射前应向患者说明本产品的适用范围、禁忌证、注意事项、不良事件以及注射方式
preparation原文未报告Not reported
storage after preparation包装开启后须一次性使用完本品，禁止开封后长时间反复使用；包装破损请勿使用

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20253130390 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20253130390 change

    官网变更：载明生产地址由:上海市闵行区江月路999号3幢201、206-210室;载明生产地址变更为:上海市闵行区江月路999号7幢1-3层、4层403室，3幢201、206-210、508、520室

  3. CN

    国械注准20253130390 change

    载明生产地址由:上海市闵行区江月路999号3幢201、206-210室;载明生产地址变更为:上海市闵行区江月路999号7幢1-3层、4层403室，3幢201、206-210、508、520室

  4. CN

    国械注准20253130390 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

3
  • 国械注准20253130390: 官网变更：载明生产地址由:上海市闵行区江月路999号3幢201、206-210室;载明生产地址变更为:上海市闵行区江月路999号7幢1-3层、4层403室，3幢…2025-11-10
  • 国械注准20253130390: 载明生产地址由:上海市闵行区江月路999号3幢201、206-210室;载明生产地址变更为:上海市闵行区江月路999号7幢1-3层、4层403室，3幢201、2…2025-11-10
  • 国械注准20253130390: certificate issued2025-02-17

Sources

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