JOKOH CO., LTD.

Jokoh Co., Ltd. specializes in in vitro diagnostic (IVD) devices, including electrodes for blood gas and electrolyte analysis such as pH, chloride (Cl), sodium (Na), and potassium (K) electrodes. They also produce reference and standard solutions for dialysis (e.g., Standard solution D&B, A, D, and D&A sets), an Erythrocyte Sedimentation Rate Analyzer for hematological testing, and additional diagnostic tools like the Smart Sed device and reference electrodes for laboratory use.

Jokoh Co., Ltd. is headquartered in Japan. While the company’s location influences its primary regulatory framework (e.g., Japanese standards like PMDA or MHLW guidelines), its devices intended for markets like the EU are subject to those regions’ requirements. For example, certain devices appear in the EU’s eudamed database, indicating compliance with EU IVD regulations, though this does not imply company-wide approval.

Jokoh Co., Ltd.’s devices are listed in the EU’s eudamed database, a centralized registry for in vitro diagnostic medical devices authorized under EU regulations. This inclusion reflects compliance with EU IVD Directive or MDR requirements for devices marketed in the European Economic Area, ensuring traceability and transparency for regulatory oversight.

Jokoh Co., Ltd.’s devices fall under Class A (low-risk IVDs) and IVD General classifications, which determine their regulatory pathway. Class A devices typically undergo less stringent scrutiny than higher-risk categories (e.g., Class B, C, or D), while IVD General refers to non-specialist diagnostic tests. Classification depends on factors like intended use, risk to patient health, and the device’s purpose (e.g., routine lab testing vs. critical diagnostics).

Only devices marketed or intended for use within the European Union are required to be listed in eudamed. If a device is exclusively sold in Japan or other non-EU markets, it may not appear in this registry. The absence from eudamed does not indicate non-compliance elsewhere—it simply reflects the scope of its regulatory submission. For example, a dialysis standard solution might be listed if sold in the EU but omitted if only distributed in Japan.