TRIANGEL is a manufacturer, not a middleman
1.We are a professional manufacturer of medical laser equipment, our endolaser with dual wavelength 980nm 1470nm has obtained US Food and Drug Administration (FDA)'s medical device product certification.
✅The Food and Drug Administration (FDA) is the US body responsible for protecting public health, ensuring the safety of different product categories such as drugs, food products, medical devices, cosmetics, and products that emit radiation, (…).The FDA also alerts healthcare professionals and the public (if necessary) when problems arise with the devices to ensure their proper use and the health and safety of patients.
�� Our laser device with dual wavelength 980nm 1470nm are FDA certified, guaranteeing the quality and reliability of TRIANGEL products worldwide.
2.Our production and manufacturing are strictly in compliance with China's medical device quality management system and ISO13485 （not ISO9001, 9001 is not a mandatory management system) medical device quality system, and have been committed to providing users with provide users with legal, compliant, safe and effective products.
✅ISO certifications represent an important tool for proving the compliance of business process management systems with the standards defined by technical standards.
��️ ISO 13485 is instead a quality certification referring exclusively to medical devices, according to the requirements and regulations of the European Union. It certifies a company's ability to provide medical devices and related services that comply with customer requirements and mandatory regulations.
3.Safety is a must for us. Every day we Triangel walk the road towards the safety of our devices, respecting the certifications required by the laws on electro-medical devices. The abbreviation CE indicates "European Conformity" and represents compliance with the EU safety directive. The latter ensures that a product has passed ad hoc tests and that, therefore, it can be distributed anywhere within the European Union and the European Economic Area.
What you can Expect from Triangel?
1.Core parts of our machine is from USA, the standards and requirements for all components and materials of medical equipment are very clear. Key components such as switching power supplies, emergency stop switches, key switches, lasers, etc. must comply with medical standards. General laser equipment does not need to meet these demanding standards, so the cost is much lower.
2.Clinical training and support
We have a large number of distributors, doctors and clinical professors around the world, which will ensure that when you purchase TRIANGEL products, you will have more clinical solutions, processes and technical support, making your surgery smoother and more effective.
3.Warranty and After-sales
The expected service life of the product is no less than 5-8 years according to the medical device. Within 18 months warranty period, if it is not damaged by human factors, our company will provide free after-sale service.
Post time: Mar-12-2025