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美德妥Medytox Inc.含利多卡因注射用交联透明质酸钠凝胶Fillux Volume Lidocaine

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美德妥Medytox Inc. is a Hyaluronic acid filler product (Class III device), registered by 美德妥Medytox Inc.. Linked registrations: China 国械注进20263130347. First approved in China on 2026-09-21 (国械注进20263130347). Data as of 2026-10-28.

  • Regulatory classHyaluronic acid filler · Class III device
  • Holder美德妥Medytox Inc.
  • JurisdictionsCN · TW
  • Updated2026-10-28 · v1

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

Registration and basics

美德妥Medytox Inc.

Product
Regulatory class
Class III device
Category
Hyaluronic acid filler
China · NMPA device registration
国械注进20263130347
Name on registration
含利多卡因注射用交联透明质酸钠凝胶Fillux Volume Lidocaine
Registrant
美德妥Medytox Inc.
China agent
泰格捷通（北京）医药科技有限公司
First approval
2026-09-21
This certificate issued
2026-09-21
Valid until
2031-09-20
Models and sizes
NVL-BO、NVL-NO、NVL-NNT1
Checked against official page
2026-10-28

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

AttributeTaiwan label (not China-approved)
Indications中脸凹陷：用于矫正中脸（前内侧脸颊、颧骨下方区域、颧骨周围）的凹陷；注射位置为骨膜上方或皮下。
Contraindications有链球菌相关疾病的病人。; 已知对利多卡因或酰胺类局部麻醉药过敏的病人。; 有自体免疫病史的病人。; 有血液凝结异常的病人。
Composition玻尿酸凝胶20 mg/mL、利多卡因盐酸盐3 mg/mL、磷酸盐缓冲生理盐水，pH=7；足量。
Storage保存温度2~25°C；避免阳光直射。
Shelf life保存期限详见原厂包装外盒（见包装标示的失效日期）。
Injection depth中脸：将产品缓慢注入真皮深层、骨膜上方或皮下。
Recommended dose中脸（前内侧脸颊、颧骨下方区域、颧骨周围）：单一疗程每一注射部位最大注射剂量不超过2 mL，单次疗程总注射剂量不超过4 mL；需在医师评估和病人同意下方可再次治疗。
Duration效能维持时间约24周。
Adverse reactions上市后经验：上市后经验：本产品上市后曾有以下不良反应案例，包括痒感、红疹、水肿、注射部位肿胀、注射部位发生红斑、注射部位产生硬块。; 误注入血管：玻尿酸植入物曾发生与误注入血管相关的罕见但严重颜面部副作用，包括暂时或永久视力损伤、失明、脑部缺血、脑部出血、中风、皮肤坏死及颜面内部结构损伤。; 注射后因注射部位压力增加，可出现瘙痒或疼痛，或产生发炎反应（发红、水肿、红斑等）；这些反应可持续数小时至数天，一些案例可持续一周。
Warnings本产品含有利多卡因，可能造成禁药测试出现阳性结果，运动员接受治疗时必须被事先告知。; 建议在注射后24小时内不要化妆，且在注射后的两周内，避免长时间暴露于阳光下、UV光下、低温中或使用三温暖及蒸气浴。; 正在接受抗凝血治疗的病人必须特别小心，并提醒他们注射时容易有血肿与出血；补充高剂量维生素E可能增加出血及瘀青。; 使用本产品时，不得同时进行激光、聚焦超声、电波拉皮及化学性换肤或磨皮治疗。; 请勿将本产品注射于骨膜上方或皮下以外之部位。; 请勿将本产品注射在有发炎和/或有感染问题的区域。
preparation无法核实（摘录对不上原文或原件无法识别）Could not verify
storage after preparation无法核实（摘录对不上原文或原件无法识别）Could not verify

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. Columns other than China reflect what was approved there, for reference only, not what China approved. 22 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20263130347 first approved

  2. CN

    国械注进20263130347 change

    首次获批（受理号 JQZ2500079；2026年09月22日医疗器械批准证明文件送达信息）

  3. CN

    国械注进20263130347 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
  • 国械注进20263130347: 首次获批（受理号 JQZ2500079；2026年09月22日医疗器械批准证明文件送达信息）2026-09-21

Sources

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