Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018179381

FEI Number

3018179381

Entity Name

PURENUM GMBH

City/State/Country

Bremen, DE

Establishment Address

Fahrenheitstrasse 1, Bremen 28359, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Purenum GmbH (Owner Number: 10070060)

Owner / Operator Contact Address

Fahrenheitstrasse 1, Bremen, DE-HB 28359, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

mediNiK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONJ	Dissolvable Gel For Preventing Ureteral Stone Migration	Gastroenterology, Urology	Class 2	876.4680	2021-02-09

Official Correspondent

Manfred Peschka

US Agent Details

Sony Janampally Business: Parexel International Email: us-agent@parexel.com Phone: (978) 5456290

Related Public Records

Same Entity

Purenum GmbH

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

View Entity Profile →

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3043617526	AD SCIENTIAM	Paris Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018179381. Last updated year: 2026. Please use registration number 3018179381 when referencing this establishment in official correspondence.