Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010369852

FEI Number

3010369852

Entity Name

AUG. HEDINGER GMBH & CO. KG

City/State/Country

Stuttgart Baden-Wurttemberg, DE

Establishment Address

Heiligenwiesen 26, Stuttgart Baden-Wurttemberg 70327, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Aug. Hedinger GmbH & Co. KG (Owner Number: 10091275)

Owner / Operator Contact Address

Heiligenwiesen 26, Stuttgart, DE-BW 70327, DE

Initial Importer Flag

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
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2024-08-08

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Aug. Hedinger GmbH & Co. KG

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011661720	TRUCKEE APPLIED GENOMICS INC	Reno, NV, US
3005504113	KEMENTEC SOLUTIONS AS	Taastrup Hovedstaden, DK
3005181013	TAKARA BIOTECHNOLOGY (DALIAN) CO., LTD.	Dalian Liaoning, CN
3006537286	AUTOBIO DIAGNOSTICS CO., LTD.	Zhengzhou Henan, CN
3036685103	REAGENT	Runcorn Cheshire West and Chester, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010369852. Last updated year: 2026. Please use registration number 3010369852 when referencing this establishment in official correspondence.