一国三证｜奥精医疗三大产品线完成泰国布局

Thailand

Three Product Lines, One Market

｜一国三证｜

奥精医疗三大产品线完成泰国布局

Allgens Medical Completes

Its Presence in Thailand

2026

ALLGENS

近日，奥精医疗旗下神经外科产品SkuHeal矿化胶原人工颅骨修复材料正式获得泰国食品药品监督管理局（TFDA）批准，取得泰国第四类（Class 4 Non-IVD）医疗器械注册证，有效期至2030年12月31日。

Recently, SkuHeal Mineralized Collagen Cranial Bone Graft Material, Allgens Medical’s neurosurgical product, received approval from the Thailand Food and Drug Administration (TFDA) as a Class 4 Non-IVD medical device. The registration is valid through December 31, 2030.

继BonGold人工骨修复材料、OssaNova矿化胶原口腔骨修复材料相继完成泰国注册后，SkuHeal的获批标志着奥精医疗骨科、神经外科、口腔三大核心产品线均已完成泰国市场布局。

Following the successful registrations of BonGold Artificial Bone Graft Material and OssaNova Mineralized Collagen Dental Bone Graft Material in Thailand, the approval of SkuHeal marks the completion of Allgens Medical’s presence across its three core product lines—orthopedics, neurosurgery, and dental applications—in the Thai market.

从骨科到神外，再到口腔，一个更加完整的海外产品矩阵正在泰国逐步形成，也为进一步服务当地不同临床专科需求奠定了基础。

From orthopedics to neurosurgery and dental regeneration, Allgens Medical is steadily building a more comprehensive overseas product portfolio in Thailand, laying a stronger foundation for meeting the diverse needs of different clinical specialties.

PART01

From One Product to Three Clinical Product Lines

从一款产品，到三条临床产品线

海外市场的拓展，从来不是单一产品的突破，而是产品体系的不断完善。OssaNova矿化胶原口腔骨修复材料率先完成泰国注册，进入口腔市场；BonGold人工骨修复材料随后完成注册，进一步拓展骨科领域布局；如今，随着SkuHeal正式获得TFDA批准，奥精医疗海外产品体系再次延伸至神经外科。

Expanding into overseas markets has never been about the success of a single product. It is a continuous process of building a comprehensive product portfolio. OssaNova Mineralized Collagen Dental Bone Graft Material was the first to receive approval in Thailand, opening the dental market. BonGold Artificial Bone Graft Material followed, further strengthening Allgens Medical’s orthopedic portfolio. Today, with the TFDA approval of SkuHeal, the company’s overseas product portfolio has expanded into the field of neurosurgery.

至此，奥精医疗三大核心产品线均已完成泰国注册，覆盖骨科、神经外科及口腔三大临床领域。三张注册证背后，不仅意味着三款产品获得市场准入，更意味着奥精医疗正以更加完善的产品矩阵，为国际合作伙伴提供更加丰富的临床解决方案。

All three core product lines have now obtained regulatory approval in Thailand, covering orthopedics, neurosurgery, and dental applications. Beyond market access for three products, these registrations reflect Allgens Medical’s commitment to providing international partners with a broader range of clinical solutions through a more complete product portfolio.

ALLGENS

PART02

Advancing Neurosurgery with Innovative Biomaterials

聚焦神经外科，让创新材料服务更多临床需求

根据TFDA注册文件，SkuHeal Bone Graft Material属于第四类（Class 4 Non-IVD）医疗器械，适用于开颅钻孔、去骨瓣减压、铣钻形成骨缺损以及其他神经外科手术所造成的颅骨缺损修复；产品可与自体骨髓或自体骨联合使用，并在修复过程中逐步被新生骨组织替代。

According to the TFDA registration, SkuHeal Bone Graft Material is classified as a Class 4 Non-IVD medical device. It is indicated for the repair of cranial defects resulting from burr holes, decompressive craniectomy, craniotomy, and other neurosurgical procedures. The material may be used in combination with autologous bone marrow or autologous bone, and is gradually replaced by newly formed bone during the healing process.

依托矿化胶原仿生材料技术平台，SkuHeal针对颅骨修复临床需求开发形成多种规格型号，为不同类型的颅骨缺损提供相应解决方案，也进一步丰富了奥精医疗在神经外科领域的产品布局。

Built upon Allgens Medical’s mineralized collagen biomimetic technology platform, SkuHeal is available in multiple specifications to address different types of cranial defects, further enriching the company’s neurosurgical product portfolio.

THAILAND

PART03

From Individual Product Approvals

to a Systematic Global Strategy

海外布局，从”单点突破”迈向”系统布局”

近年来，奥精医疗持续推进海外市场建设，不断完善全球注册体系和国际合作网络。

.In recent years, Allgens Medical has continued to strengthen its global presence by expanding international registrations and enhancing its worldwide collaboration network.

从OssaNova到BonGold，再到SkuHeal，奥精医疗正在逐步构建覆盖不同临床领域的海外产品体系。产品准入只是国际化发展的第一步，更重要的是围绕不同专科需求，持续建立产品、学术与临床之间的长期连接，为全球医生和患者提供更多基于矿化胶原技术的创新解决方案。

From OssaNova to BonGold, and now SkuHeal, Allgens Medical is steadily establishing an international product portfolio spanning multiple clinical specialties. Regulatory approval is only the first step in global expansion. More importantly, the company remains committed to building long-term connections between innovative products, academic research, and clinical practice, delivering more mineralized collagen-based regenerative solutions to healthcare professionals and patients around the world.

每一张注册证，都是一次新的起点；每一次产品拓展，也都是海外布局不断完善的重要一步。

Every registration marks a new beginning, and every product approval represents another important milestone in strengthening Allgens Medical’s global presence.

未来，奥精医疗将继续依托矿化胶原核心技术，持续推进更多产品在全球市场的注册与应用，不断丰富海外产品矩阵，让源自中国的再生医学创新惠及更多国家和地区。

Moving forward, Allgens Medical will continue to leverage its mineralized collagen core technology to advance product registrations and clinical applications worldwide, further expanding its international product portfolio and bringing regenerative medicine innovations developed in China to more countries and regions.

(奥精医疗 动态宝)