Fertsy Oocyte Retrieval Pump Receives Certification in Japan

Following its U.S. FDA 510(k) clearance, the oocyte retrieval pump from Fertsy Inc has received medical device certification in Japan through its local partner, TKB Corporation. This marks another milestone in Fertsy’s international expansion in assisted reproductive technology.

The device is registered in Japan under the generic name “電動式採卵用吸引器” (electrically powered aspirator for oocyte retrieval) and the trade name “tkbアスピレーションポンプ” (tkb Aspiration Pump), with certification number 308ADBZX00071000.

This certification follows the pump’s U.S. FDA 510(k) clearance and marks another step in bringing Fertsy’s independently developed reproductive medical devices to international markets.

From China to the United States, and Now Japan

Japan has a well-established assisted reproduction sector and is one of the world’s major markets for in vitro fertilization (IVF). Its medical device market is known for stringent regulatory, quality, and clinical requirements.

Certification provides a pathway for the pump to enter the Japanese market. It also marks further progress in Fertsy’s product quality, engineering, manufacturing, and regulatory capabilities.

Fertsy worked closely with TKB Corporation to prepare the product documentation, technical files, and regulatory submission. We thank the TKB team for its expertise and sustained commitment throughout the process.

The TKB Group traces its roots to Tokyo Kikai Boeki Co., Ltd., founded in 1955 and later renamed Tokibo Co., Ltd. The company was established to bring advanced medical devices from Europe and the United States to Japan. TKB has extensive experience in IVF and obstetric and gynecological devices, supported by a longstanding presence in Japan’s reproductive healthcare sector.

This certification reflects sustained collaboration between the two teams and another step forward in Fertsy’s international development.

A Compact Device, Built for Reliability

Oocyte retrieval is a key step in IVF treatment. Designed for this procedure, the Fertsy oocyte retrieval pump provides stable, precise control of negative pressure to support clinical use.

We believe that excellent medical devices do not have to be complex, but they must be reliable.

From research and development to quality management, manufacturing, and regulatory submissions, Fertsy develops its products to meet the requirements of international medical device markets.

Fertsy has established quality management systems based on ISO 13485 and ISO 9001. Following its U.S. FDA 510(k) clearance, the oocyte retrieval pump has now received certification in Japan. Access to these two major medical device markets provides a foundation for the next stage of development.

Bringing AI and Medical Devices to Global Reproductive Care

Founded in 2023, Fertsy Inc focuses on the intersection of artificial intelligence and reproductive medicine. Guided by the needs of fertility clinics and embryology laboratories, the company is building a portfolio spanning AI-assisted embryo assessment, smart embryology laboratory solutions, cryostorage safety monitoring, oocyte retrieval devices, and intelligent embryo culture equipment.

The EmbryoInsights™ AI embryo assessment system has been evaluated in a prospective clinical study and has obtained Class II medical device registration in China. Fertsy is also working to introduce CryoTrio™, its intelligent liquid nitrogen storage monitoring system, in several overseas markets.

From research and development in China to international clinical collaboration, from AI software to medical devices, and from U.S. FDA clearance to certification in Japan, Fertsy is bringing reproductive technologies developed in China to the world.

Certification in Japan is the beginning of the next phase: helping more fertility clinics across the country adopt the pump in clinical practice.

We look forward to continuing our collaboration with TKB Corporation to support its introduction in Japan, and to seeing more medical technologies developed in China serve fertility clinics worldwide.