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Erika, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
43

What Erika, Inc. makes

Erika, Inc. manufactures a range of renal replacement and related medical devices, including hemodialysis filters such as the ERIKA HPF series (50, 100, 200, 300), the MICRO-COIL 100 coil dialyzer, and the MAGNIFLO 100 parallel plate dialyzer, as well as accessories like the ERIKA CAPD prep kit, the DI-ALA single‑use dialysis kit, a negative pressure arterial blood line, fistula needles, and an infusion pump set.

These products are classified as Class I or Class II medical devices and are listed in the FDA 510(k) database. Erika, Inc. is based in the United States.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Erika, Inc. have in the registry?

The registry currently lists 43 devices for Erika, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Erika, Inc.'s devices?

Among its 43 most recently registered devices, Erika, Inc. has devices listed in FDA 510(k) (43 devices).

What risk classes do Erika, Inc.'s devices fall under?

Among its 43 most recently registered devices, the classes recorded for Erika, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Erika, Inc. in the registry?

The most recently registered devices listed for Erika, Inc. include ERIKA HPF 100, MICRO-COIL 100 COIL DIALYZER, ERIKA HPF 300 and TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2.

Generated automatically from registry data and not verified by a human reviewer.