Gerresheimer Regensburg GmbH

FDA Device Registration & Listing · Wackersdorf Bavaria, DE · Registration 3012529833

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012529833
FEI Number
3012529833
Entity Name
Gerresheimer Regensburg GmbH
City/State/Country
Wackersdorf Bavaria, DE
Establishment Address
Oskar-von-Miller-Strasse 6, Wackersdorf Bavaria 92442, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Gerresheimer Regensburg GmbH (Owner Number: 10030618)
Owner / Operator Contact Address
Kumpfmuehlerstrasse 2, Regensburg, DE-BY 93047, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2024-11-19

Official Correspondent

Paula Schmidt

US Agent Details

Adelaido Angel Business: Gerresheimer Peachtree City, L.P. Email: adelaido.angel@gerresheimer.com Phone: (770) 5894157

Related Public Records

Same Entity

Gerresheimer Regensburg GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013445959 Gerresheimer Peachtree City, L.P. Peachtree City, GA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012529833. Last updated year: 2026. Please use registration number 3012529833 when referencing this establishment in official correspondence.
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