Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Resolution Biomedical, Inc.

United States·US-MF-000029623

Last updated September 18, 2026

About

Resolution Biomedical, Inc. (“RBI”) was founded in 2009 to develop ClearPrep, an innovative liquid-based cytology system.

From the manufacturer's own website. Source

What Resolution Biomedical, Inc. makes

Resolution Biomedical, Inc. manufactures the ClearPrep system, a liquid-based cytology device designed for sample preparation in cytological testing. The system is intended for use in laboratory settings to process and preserve cellular specimens for microscopic examination, reducing manual handling and improving sample quality.

The ClearPrep system is classified as a Class A medical device and is listed in the EU’s eudamed registry. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Resolution Biomedical, Inc. manufacture?

Resolution Biomedical, Inc. specializes in the ClearPrep system, a liquid-based cytology device. This device is designed for laboratory use to prepare and preserve cellular samples for cytological testing, aiming to minimize manual handling and enhance sample quality for microscopic analysis.

Where is Resolution Biomedical, Inc. based?

Resolution Biomedical, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly when considering device compliance and distribution.

In which regulatory registries are Resolution Biomedical, Inc.’s devices listed?

The ClearPrep system is listed in the EU’s eudamed registry, which serves as a central database for medical devices authorized within the European Economic Area. Listing in eudamed ensures transparency and traceability of the device’s regulatory status.

How are Resolution Biomedical, Inc.’s devices classified under medical device regulations?

The ClearPrep system falls under Class A classification for medical devices. This classification is typically assigned to devices posing minimal risk, such as those with non-invasive procedures or low-risk applications, which aligns with its intended use in sample preparation for cytology.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
1342, Bell Avenue, Tustin, California, United States
LinkedIn
—
Facebook
—
Phone
+1 949 551 8000
PRRC Contact
James Smith
EUDAMED SRN
US-MF-000029623
FDA FEI Number
—
DUNS Number
—

Catalogue (5)

DeviceModel / ReferenceRegistriesClassStatus
ClearPrep CP1LABV
EUDAMED
Class AActive
ClearPrep CP11007
EUDAMED
Class AActive
ClearPrep CP13001
EUDAMED
Class AActive
ClearPrep CP11006
EUDAMED
Class AActive
ClearPrep CP1LP25
EUDAMED
Class AActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.