To Know SeamatyQuality CommitmentCertificates & Patents

Quality Commitment

Management System

Seamaty has passed ISO 13485:2016 international quality management system certification issued by TUV Rheinland and national intellectual property management system certification.

Research & Development

14.8%

Investment

70+

Professionals

2

R&D Center

The average annual R&D spending of annual revenues in the past five years is 9.55%, 14.8% in 2020. Seamaty has been continuously recognized as national high-tech enterprise and Gazelle company. We have two R&D centers located in Chengdu and Shenzhen, with a total team over 70. We have applied 56 patents, including utility patents, design patents, software patents and international patents.

Quality Control

Our factory has built GMP level cleanrooms for production with first class laboratories for products testing. We have introduced a variety of imported equipment with 3 advanced automated production lines, skilled workers and professional quality control team to ensure premium product quality.

Standard Laboratory

Seamaty has built first class laboratories, including GMP 10,000 level. Our products have passed rigorous tests in vibration, power surges, shock and other aspects, to ensure the reliability and safety of clinical use in different environments.

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Number of particles/m³

≥ 0.5μm max. at 350000
≥ 5.0μm max. at 2000

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Microbial contamination

Airborne microbe: max. 100/m³
Settling microbe: 3 per plate

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Air exchange

20 per hour

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Temperature and humidity

Temperature: 18-28 deg C,Humidity: 45-65%

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Pressure difference

≥ 10Pa clean area and unclean area
≥ 5Pa adjacent cleanrooms

Reliability Testing

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Withstand voltage test

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Grounding resistance test

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Reagent contrast

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Reagent disc inspection