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Kla Hepburn Pure Water Light (Hialuronic SA)Kla Hepburn Sodium Hyaluronate Solution (Skin Hydration)

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Kla Hepburn Pure Water Light (Hialuronic SA) is a Skin booster product (Class III device), registered by 海雅美生物技术（珠海）有限公司. Linked registrations: China 国械注准20253130898. Data as of 2026-10-23.

  • Regulatory classSkin booster · Class III device
  • Holder海雅美生物技术（珠海）有限公司
  • JurisdictionsCN
  • Updated2026-10-23 · v1

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

Registration and basics

Kla Hepburn Pure Water Light (Hialuronic SA)

Product
Regulatory class
Class III device
Category
Skin booster
China · NMPA device registration
国械注准20253130898
Name on registration
注射用透明质酸钠溶液
Registrant
海雅美生物技术（珠海）有限公司
First approval
Not obtained from an official source
This certificate issued
2025-04-30
Valid until
2030-04-29
Models and sizes
型号：ANN0012规格：0.5 mL、1 mL、1.5 mL、2 mL、2.5 mL、3 mL
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面部：在医疗机构中使用，用于面部真皮浅层注射，暂时性改善成人皮肤干燥、肤色暗沉
Contraindications本产品不得用于眶周注射; 已知对透明质酸和/或链球菌蛋白质过敏者; 处于皮肤疱疹发作期、皮肤感染期的患者; 孕妇、哺乳期妇女、备孕期妇女和未成年人; 凝血机制异常，或正在接受血栓溶解剂、抗凝剂治疗者; 本产品不得用于乳房部位注射; 易于形成瘢痕疙瘩、增生性瘢痕或其他任何愈合异常者; 处于过敏发作期的患者; 多疗程注射的安全有效性未经验证
Composition溶液由透明质酸钠和磷酸盐缓冲体系组成；透明质酸钠由微生物发酵法制备，标示浓度12mg/mL
Storage原文未报告Not reported
Shelf life货架有效期2年
Injection depth面部：面部真皮浅层注射
Recommended dose原文未报告Not reported
Duration原文未报告Not reported
Adverse reactions临床试验：临床试验期间共186例(45.04%)受试者发生381例次不良事件，其中试验组153例(56.04%)发生329例次，对照组33例(23.57%)发生52例次；注射相关不良反应均为同类产品常见，严重程度多为轻到中度，大多可在1-2周内自行恢复
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20253130898 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20253130898 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20253130898: certificate issued2025-04-30

Sources

6