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BeloteroBelotero Soft (Lidocaine)

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Belotero is a Hyaluronic acid filler product (Class III device), registered by Anteis SA. Linked registrations: EU 764012379DF10101SJ, UK PARD-6256778, UK PARD-5799501 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

Product
Regulatory class
Class III device
Category
Hyaluronic acid filler
EU · EUDAMED device record
764012379DF10101SJ
UK · MHRA device registration (not an approval)
PARD-6256778
UK · MHRA device registration (not an approval)
PARD-5799501
UK · MHRA device registration (not an approval)
PARD-5378791
Australia · TGA ARTG device
291726
Name on registration
Belotero Soft Lidocaine
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 764012379DF10101SJ; 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目标人群：适用于存在该器械治疗适应症且无禁忌证的成年人，不限性别; 口周细纹：用于注射至真皮浅层至中层，治疗口周细纹
Contraindications未满18岁者禁用; 妊娠期和哺乳期女性禁用; 不得注射入眉间或鼻部区域; 不得注射入曾使用永久性真皮填充剂治疗的部位; 不得注射入血管内; 存在全身性感染者禁用; 患有活动性自身免疫疾病者禁用; 对产品某一成分已知过敏者禁用，尤其是对透明质酸钠、BDDE、盐酸利多卡因或其他酰胺类局部麻醉药过敏; 不得注射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）
Composition透明质酸钠20 mg/ml；盐酸利多卡因3 mg/ml；pH7磷酸盐缓冲液适量至1 ml；BDDE残留≤2 ppm; 生理磷酸盐缓冲液：含氯化钠8 mg/ml、磷酸二氢钠二水合物0.5 mg/ml、磷酸氢二钠十二水合物2.4 mg/ml，溶于注射用水
Storage在2°C至25°C之间储存，避光，避免机械冲击，不可冷冻，保持干燥
Shelf life原文未给出具体有效期时长，须查看注射器与针头的失效日期（EXP）以及无菌屏障完整性是否有破损
Injection depth口周纹注射用针头：每盒含1支预充1 ml凝胶的注射器和2支仅限一次性使用的无菌CE标志针头（2×30G½英寸）; 口周细纹：注射至真皮浅层至中层，用于治疗口周细纹
Recommended dose口周纹：口周纹每次治疗最大体积为3 mL，或分两次注射（间隔至少2至4周）共最多4 mL；根据个人需求可在6个月后再次治疗，年最大剂量为8 ml
Duration基于临床数据：基于临床数据，效果至少可维持6个月
Adverse reactions面部：面部软组织填充剂血管内注射相关罕见但严重的不良事件已有报告，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 underlying 面部结构的损伤; 注射部位：注射后可能出现注射部位反应，但数天内自行消退，包括肿胀、结节或硬块、瘀伤/紫癜、血肿、瘀斑、硬结、红斑/发红、压痛、疼痛、变色、瘙痒、刺痛、感觉异常、麻木、感觉减退、结痂、针痕以及不适或刺激; 利多卡因：与利多卡因给药相关的全身反应不太可能发生，但不能排除，因为其仅局部使用且浓度/剂量小
Warnings联合治疗：关于BELOTERO产品与肉毒毒素和/或羟基磷灰石联合使用的临床数据有限；作为预防措施，应将各产品注射于不同面部区域; 建议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，并确保患者了解潜在并发症的体征和症状; 联合治疗：在上一次治疗完全愈合前，不得与其他美容技术（如换肤、皮肤磨削或任何类型的激光治疗）联合使用；即使愈合更早，也不得在上一次治疗后2周内使用; 利多卡因剂量：每次治疗推荐的填充剂最大体积3 ml相当于9 mg利多卡因；若同时使用利多卡因或在填充治疗期间接受其他局麻药，应考虑到对于正常健康成人，建议每次治疗盐酸利多卡因（不含肾上腺素）总剂量不超过300 mg（或4.5 mg/kg）; 对有链球菌疾病史者以及有肥厚性瘢痕或瘢痕疙瘩倾向者，不建议注射本品; 面部软组织填充剂血管内注射：若出现视力改变、卒中征象、皮肤发白或操作过程中/操作后不久异常疼痛等症状，医护人员应立即停止注射; 合并用药：注射前10天至注射后3天使用抗凝、抗血小板或溶栓药物（如华法林）、抗炎药物（口服/注射用糖皮质激素或非甾体抗炎药，如阿司匹林、布洛芬）或其他已知可延长凝血时间的物质（维生素或草药补充剂，如维生素E、大蒜、银杏叶和贯叶连翘）者，注射部位血肿、结节或出血反应可能增加; 过敏史：对有严重多种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，因为注射可能加重其现有健康状况
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. 32 of them are not yet reviewed by a person.

Registration timeline

  1. AU

    291726 ARTG start date

  2. UK

    PARD-5378791 registered

  3. UK

    PARD-5799501 registered

  4. UK

    PARD-6256778 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-6256778: registered2026-08-12
  • PARD-5799501: registered2026-03-03
  • PARD-5378791: registered2025-06-24

Sources

12