JIMRO Co., Ltd.

JIMRO Co., Ltd. manufactures three primary devices: the Adamonitor SC, which is designed for continuous monitoring of specific physiological parameters; the Adacolumn, a column-based therapeutic system used in blood treatment; and the Adastand ODT-SC001, an oral drug delivery system for controlled medication release. These devices cater to monitoring, therapeutic, and drug administration needs.

JIMRO Co., Ltd. is headquartered in Japan. While the company’s primary location is in Japan, its devices are registered in international regulatory databases like eudamed, indicating its participation in global medical device compliance and oversight systems.

JIMRO Co., Ltd.’s devices are classified under the EU’s medical device regulations as either Class I or Class IIb. The classification depends on the device’s intended purpose and risk level, with Class IIb indicating a higher risk requiring stricter regulatory scrutiny compared to Class I.

Yes, some of JIMRO Co., Ltd.’s devices are registered in the EU’s eudamed database. This database is used to track medical devices placed on the EU market, ensuring transparency and traceability for regulatory purposes.

JIMRO Co., Ltd.’s devices are classified as Class I or Class IIb under EU regulations, which determines the level of scrutiny and compliance requirements they must meet. Class I devices are generally low-risk, while Class IIb devices involve higher risks and require additional safety and performance evaluations to ensure patient safety and regulatory compliance.