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Belotero Revive764012379DF00101S7

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Belotero Revive is a Hyaluronic acid filler product (Class III device), registered by Anteis SA. Linked registrations: EU 764012379DF00101S7, UK PARD-6265369, UK PARD-6265371 and 2 more. Data as of 2026-11-09.

  • Regulatory classHyaluronic acid filler · Class III device
  • HolderAnteis SA
  • JurisdictionsEU · UK · AU
  • Updated2026-11-09 · v1

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

Registration and basics

Belotero Revive

Product
Regulatory class
Class III device
Category
Hyaluronic acid filler
EU · EUDAMED device record
764012379DF00101S7
UK · MHRA device registration (not an approval)
PARD-6265369
UK · MHRA device registration (not an approval)
PARD-6265371
UK · MHRA device registration (not an approval)
PARD-6265372
Australia · TGA ARTG device
427857
Registrant
ANTEIS SA
First approval
Not obtained from an official source
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.Registrant and dates are from 764012379DF00101S7; 5 registrations linked.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

AttributeUK label (not China-approved)
Indications面部皮肤：为可注射、可吸收的植入物，用于通过为干燥及极干燥皮肤补水、改善弹性与紧致度、并通过降低皮肤粗糙度抚平浅表细纹，以实现面部皮肤焕活; 面颊部：用于面颊部早期光老化皮肤的重塑（revitalization），其特征为皮肤脱水、弹性与紧致度下降以及存在浅表细纹; 适用于有该器械治疗适应症且无禁忌证的成年人，不限性别
Contraindications不得注入存在活动性皮肤炎症或感染的皮肤区域（如免疫性、过敏性、细菌性、真菌性或病毒性原因所致）; 眉间、鼻部：不得注入眉间或鼻部区域; 存在全身性感染者; 存在活动性自身免疫性疾病者; 不得注入血管内; 不得注入既往曾使用永久性真皮填充剂治疗的部位; 对产品某一成分已知过敏者，尤其是对透明质酸钠、甘油或 BDDE 过敏; 妊娠期及哺乳期女性; 未满 18 岁者
Composition使用 1,4-丁二醇二缩水甘油醚（BDDE）交联；经核磁共振波谱测定修饰度 <5%; 组成：透明质酸钠 20 mg/ml、甘油 17.5 mg/ml、pH 7 磷酸盐缓冲液加至 1.0 ml、残留 BDDE ≤2 ppm; 磷酸盐缓冲液含磷酸二氢钠二水合物 1.5 mg/ml 与磷酸氢二钠 5.5 mg/ml，溶于注射用水
Storage在 2–25 °C 之间储存；避光；避免机械冲击；不可冷冻；保持干燥
Shelf life文件未给出具体有效期时长，要求使用前特别检查注射器与针头的失效日期; 失效日期标示于标签（EXP：Use-by date）
Injection depth每盒含一支装有 1 mL 凝胶的注射器和两支一次性无菌 CE 标记针头（2 支 30G½”）; 面颊部：可注射至真皮中层至深层
Recommended dose面颊部：推荐注射技术为连续微穿刺技术：在治疗区域均匀多点注射极少量产品，每点约 50 μL，共 20–30 点，点间距约 1 或 2 cm; 面颊部：上述治疗方案最早可在 6 个月后重复，年最大剂量为 12 mL; 面颊部：面颊部可单次注射，最大体积 3 mL；或分 3 次注射，每次最大体积 2 mL，各次间隔至少 4 周
Duration基于临床数据：基于临床数据，BELOTERO Revive 的维持时间最长可达 9 个月
Adverse reactions肤色较浅者更易发生注射相关不良事件; 肉芽肿、缺血、坏死及血管阻塞的风险在深层注射、大体积注射或未获批准的解剖部位注射时更高; 注射部位：注射部位反应：皮肤注射后可能出现，数日内自行消失，包括肿胀、结节或肿块/隆起、瘀伤/紫癜、血肿、瘀斑、硬结、红斑/发红、压痛、疼痛、变色及瘙痒、刺痛、感觉异常、麻木、感觉减退、结痂、针痕和不适或刺激; 面部血管内注射：面部软组织填充剂血管内注射相关的罕见但严重不良事件已有报告，包括暂时或永久性血管并发症、视力损害、失明、脑缺血或脑出血（导致卒中）、皮肤坏死以及对面部深层结构的损伤; 动脉内注射：文献中报告了意外动脉内注射后出现视力损害或失明的孤立病例
Warnings透明质酸钠遇季铵盐类（如苯扎氯铵）会沉淀，因此建议产品不要与这类物质接触; 鼓励医护人员在治疗前与患者讨论软组织注射的所有潜在风险，并确保其了解潜在并发症的体征和症状; 严重过敏史/过敏性休克史人群：对于有多种严重过敏史或过敏性休克史者，缺乏注射本品的耐受性临床数据，医护人员须根据疾病性质及相关治疗逐例决定是否注射；建议先做双测试，疾病进展期不注射；发生过敏反应须停止注射，注射后应密切监测并备好急救条件; 在末次治疗完全愈合前，不得将本品与换肤、皮肤磨削或任何类型激光治疗等其他美容技术联用；即使愈合更早，也必须在末次治疗后至少 2 周才能使用本品; 男性、29 岁以下及 49 岁以上成人：男性以及 29 岁以下、49 岁以上成人的注射临床数据有限; 医护人员应指导患者在行 MRI 扫描前向放射科医师出示其植入卡; 若患者在术中或术后不久出现视力变化、卒中征象、皮肤发白或异常疼痛等症状，医护人员应立即停止注射
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. Columns other than China reflect what was approved there, for reference only, not what China approved. 38 of them are not yet reviewed by a person.

Registration timeline

  1. AU

    427857 ARTG start date

  2. UK

    PARD-6265369 registered

  3. UK

    PARD-6265371 registered

  4. UK

    PARD-6265372 registered

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. Dates on non-Chinese registrations keep the source's wording: UK devices show the registration date (MHRA does not approve them), Australia the ARTG start date, FDA devices the decision date.

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Recent changes

3
  • PARD-6265369: registered2026-08-17
  • PARD-6265371: registered2026-08-17
  • PARD-6265372: registered2026-08-17

Sources

13