Hangzhou Laihe Biotech Co., Ltd.

08/04/2025

We’re thrilled to share that Laihe Biotech (brand name LYHER) has successfully obtained MDSAP (Medical Device Single Audit Program) certification! This significant milestone reflects our commitment to global medical device regulatory compliance and strengthens our position in international markets.

🔹 Why Does MDSAP Certification Matter?

The MDSAP certification allows us to meet the regulatory requirements of multiple countries—including the U.S. (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), and Australia (TGA)—through a single audit. This streamlines our compliance processes and reinforces our ability to deliver high-quality, globally compliant medical devices.

🔹 What This Means for Our Customers & Partners:

✅ Faster market access in key regions

✅ Enhanced quality and compliance assurance

✅ Broader international reach

A huge thank you to our dedicated team for their hard work, and to our partners and customers for their continued trust and support. We remain committed to innovation and excellence, ensuring our medical devices meet the highest standards for safety and efficacy worldwide.

05/03/2024

Dear partners/potential clients,

We are thrilled to share the exciting news that we will be participating in Hospitalar this May in São Paulo. We can hardly contain our excitement and are eagerly looking forward to the opportunity to meet with you in person.

Hospitalar is renowned for bringing together the latest innovations and advancements in the healthcare industry, and we can't wait to showcase how our offerings can benefit you and your organization.

Mark your calendars and plan to join us at this great event. We're counting down the days and hope to meet you face in face to discuss how we can meet your needs.

For a sneak peek into our company and products, please feel free to visit our website and initiate early communication!

Website: http://www.lyherbio.com
Email: office@lyher.com

Looking forward to meeting you soon.



Warm regards,
Laihe Biotech Team

Focused on the development and industrialization of POCT instant diagnosis, monitoring and health information technology field, and is committed to, providing

12/01/2024

Awesome step forward！
We’re glad to share the exciting news that LYHER® Urine Ma*****na (THC) Test Kit (Strip/Cassette) and LYHER® Urine Multi-Drug Test Kit(Cup/Cassette/Dipcard) have obtained the U.S. FDA 510(k) approval.

Drug of abuse has become a global public health problem and a serious social problem. These two FDA 510k approved products from Hangzhou Laihe Biotech Co.,Ltd contain a variety of combinations and forms, which can be flexibly applied to different drug abuse screening scenarios.
Urine Multi-Drug Test Kit focus on some of the most common drugs listed by the U.S. Transportation Security Administration and can be used for preliminary qualitative detection of AMP/OPI/COC/THC/MET/PCP in urine. Urine Ma*****na (THC) Test Kit is mainly focused on single-item urine testing of ma*****na. In areas where ma*****na is legalized, more testing needs may arise.

The acquisition of these two certificates marks the official entry of the Laihe’s main drug testing series products into the U.S. market, helping the company to explore the U.S. drug home self-testing and POC testing market, and is also a milestone for Laihe to further expand the international market.
Laihe will be committed to introducing more drug testing series products to the U.S. market, further improve the product matrix, gradually implement and steadily promote the established strategy, and ensure deep development, refinement and strength in the fields of infectious disease and drug testing.

Contact us to find out more about product details office@lyher.com

18/08/2023

WHO Approval-LYHER Novel Coronavirus (COVID-19) Antigen Test Kit

On 10th July, LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) has been listed in the WHO EUL, which is a recognition of Laihe's production system and quality assurance, and greatly encourages Laihe's confidence in continuing to lay out the field of rapid testing for respiratory virus infections.

Laihe is committed to become a complete solution expert of rapid diagnostic reagents for respiratory diseases, and the matrix of respiratory rapid test products is being steadily improved. In addition to COVID-19 products, Laihe has also obtained EU CE registration certificates for many other respiratory products, such as LYHER COVID-19 and Influenza A/B Antigen Test Kit for self-testing, Respiratory Multiple Rapid Test (COVID-19/FluA/FluB/RSV/Adeno) and so on. Rapid tests for influenza, RSV, parainfluea, rhinovirus, adenovirus, streptococci and other respiratory related diseases are also in the process of actively promoting the filing of the IVDR and the WHO registrations.

18/08/2023

Dear partners,

We are thrilled to invite you to participate in the upcoming Medical Fair Thailand 2023, which will take place at 88 Bangna-Trad Road, Bangna, Bangkok 10260, Thailand from September 13rd to 15th. And we would love for you to come to visit us at Booth NO. G33.

Hangzhou Laihe Biotech Co., Ltd. (Brand LYHER) is an original manufacturer of IVD products based in China, specialized in the field of in-vitro diagnostics. Our company is dedicated to providing high-quality and innovative solutions for the diagnosis of infectious diseases tests, drug of abuse tests (urine/saliva/hair), cardiac marker tests, tumor marker tests and ToRCH&fertility tests.



If you are interested in visiting us, welcome to contact us in advance through email office@lyher.com. We look forward to having a great talk with you guys then!

Yours Sincerely,
Lyher team

17/08/2023

Dear partners, We are thrilled to invite you to participate in the upcoming Medical Fair Thailand 2023, which will take place at 88 Bangna-Trad Road, Bangna, Bangkok 10260, Thailand from September 12th to 15th. And we would love for you to come to visit us at Booth NO. G33. Hangzhou Laihe Biotech Co...

14/07/2023

With LYHER series products, we monitor women fertility-related hormones that suggest the best time for pregnancy and confirm the pregancy status in very early stage. We care and we do understand the importance of accurate diagnosis with reliable results in a confidential and convenient method.

11/07/2023

In recent years, drug abuse has become one of the focal points of public attention. In order to detect drug abuse more efficiently, researchers in the scientific and technological world have made continuous efforts. One of the high-profile innovations is the use of hair for drug testing.

In recent years, drug abuse has become one of the focal points of public attention. In order to detect drug abuse more efficiently, researchers in the scientific and technological world have made continuous efforts. One of the high-profile innovations is the use of hair for drug testing. So, you ...

21/06/2023

With the escalating issue of opioid and cannabis abuse, Laihe has strengthened its efforts in testing these substances. The development and application of these testing methods play a vital role in safeguarding public safety and health.

Opioids are potent pain medications, but they are also prone to addiction and misuse.

With the escalating issue of opioid and cannabis abuse, Laihe has strengthened its efforts in testing these substances. The development and application of these testing methods play a vital role in safeguarding public safety and health. Opioids are potent pain medications, but they are also prone...

06/05/2023

Dengue fever is a mosquito-borne disease that is prevalent in many parts of the world, particularly in tropical and subtropical regions. The disease is caused by the dengue virus, which is transmitted to humans through the bite of infected Aedes mosquitoes.   The symptoms of dengue fever can range ...