Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004061467

FEI Number

3004061467

Entity Name

R-BIOPHARM AG

City/State/Country

DARMSTADT Hesse, DE

Establishment Address

An der neuen Bergstrasse 17, DARMSTADT Hesse D-64297, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

R-BIOPHARM AG (Owner Number: 9058209)

Owner / Operator Contact Address

An der neuen Bergstrasse 17, --, Darmstadt, DE-HE D-64297, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RIDA® CCD-Inhibitor RIDA®GENE Norovirus GI/GII RIDASCREEN® Pancreatic Elastase ELISA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHL	Protein, Complement, Antigen, Antiserum, Control	Immunology	Class 1	866.4100	2020-11-27
PIQ	Reagents For Detection Of Norovirus Nucleic Acid	Microbiology	Class 2	866.3990	2017-09-28
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-09-28
JNN	P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin	Clinical Chemistry	Class 1	862.1725	2026-03-26

Official Correspondent

Fernanda Heiss

US Agent Details

Roshana Ahmed Business: QUARAS, LLC Email: rahmed@quarasconsulting.com Phone: (657) 2487361

Related Public Records

Same Entity

R-BIOPHARM AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3026886124	ROCGENE(XUZHOU) TECHNOLOGY LIMITED	Xuzhou Jiangsu, CN
1524213	MERIDIAN BIOSCIENCE, INC.	Cincinnati, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004061467. Last updated year: 2026. Please use registration number 3004061467 when referencing this establishment in official correspondence.