[INQ. NO. 1811C08] SEPIA MicroPigment is manufactured in a facility certified by ISO 9001 and ISO 13485 and undergoes a thorough inspection and testing in a laboratory also certified by ISO 17025.
In particular, SEPIA is produced in cleanroom ISO 5 (NASA 100) and supplied sterile by the aseptically filling process in accordance with ISO 13408-2 filtration. Its disposable use can protect against cross contamination. The main materials of SEPIA include inorganic pigments to ensure safety, biocompatibility, and long-lasting colors.
In the biocompatibility tests stipulated by ISO 10993s, SEPIA has proved its excellent cytotoxicity. Unlike other counterparts, the SEPIA does not contain any toxic materials such as formaldehyde, phenol, and paraben.
Established in 2006, The Standard Co., Ltd. specializes in the manufacture of medical devices and semi-permanent pigments. Its main products include endoscopic markers used in marking lesions in the gastrointestinal tract as well as in sepia semipermanent pigments.
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