Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004155943

FEI Number

3004155943

Entity Name

OPTOSOL CHEMISCHE PRODUKTE GMBH

City/State/Country

Miesbach Bavaria, DE

Establishment Address

Oskar-von-Miller-Strasse 6-8, Miesbach Bavaria 83714, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OPTOSOL Chemische Produkte GmbH (Owner Number: 10091875)

Owner / Operator Contact Address

Oskar-von-Miller-Strasse 6-8, Miesbach, DE-BY 83714, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal Spray with 0,9% sea salt Proponent Nasal Spray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2024-11-11

Official Correspondent

Alfred Hefft

US Agent Details

Leonard Krause Business: FDA Connect, inc. Email: Lkrause@fda-connect.com Phone: (541) 2323030

Related Public Records

Same Entity

OPTOSOL Chemische Produkte GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004155943. Last updated year: 2026. Please use registration number 3004155943 when referencing this establishment in official correspondence.