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KeruikangCollagen Solution (Injectable)

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Keruikang is a Collagen product (Class III device), registered by 浙江珂瑞康生物医疗科技有限公司. Linked registrations: China 国械注准20253131612. Data as of 2026-10-23.

  • Regulatory classCollagen · Class III device
  • Holder浙江珂瑞康生物医疗科技有限公司
  • JurisdictionsCN
  • Updated2026-10-23 · v1

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

Registration and basics

Keruikang

Product
Regulatory class
Class III device
Category
Collagen
China · NMPA device registration
国械注准20253131612
Name on registration
注射用胶原溶液
Registrant
浙江珂瑞康生物医疗科技有限公司
First approval
Not obtained from an official source
This certificate issued
2025-08-22
Valid until
2030-08-21
Models and sizes
型号：ZC40规格为：1.0 mL/支，1.5 mL/支，2.0 mL/支，2.5mL/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面部鱼尾纹：适用于面部鱼尾纹部位真皮组织注射填充，以纠正鱼尾纹
Contraindications不适用于有严重过敏及免疫性疾病史的患者; 不适用于已知对胶原蛋白过敏的患者，包括（但不限于）曾使用胶原蛋白制品（如注射剂、植入剂、止血棉、缝合线、生物胶等）后产生明显过敏现象者
Composition胶原溶液由从牛皮中提取纯化而成的胶原与生理盐水组成，胶原含量为 4.0 mg/mL
Storage原文未报告Not reported
Shelf life货架有效期为 24 个月
Injection depth面部鱼尾纹：可注射至鱼尾纹处真皮层，起填充作用，以纠正鱼尾纹
Recommended dose原文未报告Not reported
Duration原文未报告Not reported
Adverse reactions临床试验安全性结论（观察周期 5 个月）：本次临床试验中，两组受试者的生命体征无统计学差异；试验组与对照组注射后的局部反应主要为红肿、压痛，组间无统计学差异；局部不良事件持续 1-3 天，基本在 7 天内消退; 产品受益风险判定中的风险：注射后可能发生硬结、瘙痒、疼痛、红肿、淤青、淤血、瘀斑、感染、局部炎症反应、形成瘢痕、结节、肉芽肿、过敏等不良事件
Warnings本品为胶原蛋白类面部填充材料，可能发生全身性免疫反应的风险; 使用时须避免将产品直接注射入血管中，以免产品中的胶原造成血小板凝集而导致局部血管栓塞; 须避免直接注射至正在发炎或感染的患处，例如红斑、丘疹肿、脓疱等病灶; 使用抗凝药物（如阿司匹林）或非甾体抗炎药物者，使用本产品会增加注射部位的出血程度; 多疗程注射的安全有效性未经验证; 本产品不得用于适用范围批准之外的部位注射（如乳房等）; 本产品为无菌产品，无菌屏障为预灌封注射器；使用前若发现无菌屏障破损，应立即丢弃，不得使用; 孕妇、哺乳期及备孕期妇女：本产品用于成人，孕妇、哺乳期及备孕期妇女禁用
preparation原文未报告Not reported
storage after preparation原文未报告Not reported

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. 21 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注准20253131612 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20253131612 change

    官网变更：注册人住所由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）; 载明生产地址由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）;注册人住所变更为:浙江省杭州市钱塘区下沙街道银海街1212号5幢1-3层; 载明生产地址变更为:浙江省杭州市钱塘区…

  3. CN

    国械注准20253131612 change

    注册人住所由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）; 载明生产地址由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）;注册人住所变更为:浙江省杭州市钱塘区下沙街道银海街1212号5幢1-3层; 载明生产地址变更为:浙江省杭州市钱塘区下沙街道银…

  4. CN

    国械注准20253131612 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20253131612: 官网变更：注册人住所由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）; 载明生产地址由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北…2025-12-03
  • 国械注准20253131612: 注册人住所由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）; 载明生产地址由:浙江省余杭区余杭经济开发区昌达路116号2幢2-4层（北面）;注册…2025-12-03
  • 国械注准20253131612: certificate issued2025-08-22

Sources

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