Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000570445

FEI Number

1000570445

Entity Name

CHEMISCHE FABRIK DR. WEIGERT GMBH & CO. KG

City/State/Country

Hamburg, DE

Establishment Address

Muehlenhagen 85, Hamburg 20539, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Chemische Fabrik Dr. Weigert GmbH & Co. KG (Owner Number: 10053662)

Owner / Operator Contact Address

Muehlenhagen 85, Hamburg, DE-HH 20539, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neodisher SeptoClean ProCare Dent 10 A ProCare Dent 10 MA neodisher FA neodisher MediClean forte ProCare Dent 11 A neodisher MA neodisher MultiZym neodisher N ProCare Dent 30 C ProCare Dent 30 P neodisher PreStop neodisher Z neodisher MediZym

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-08-09
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2017-02-24

Official Correspondent

Katrin Langner

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Chemische Fabrik Dr. Weigert GmbH & Co. KG

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000570445. Last updated year: 2026. Please use registration number 1000570445 when referencing this establishment in official correspondence.