Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005427465

FEI Number

3005427465

Entity Name

Polichem SA

City/State/Country

Mendrisio Ticino, CH

Establishment Address

Via Angelo Maspoli 11, Polichem SA, Via Angelo Maspoli 11, 6850 Mendrisio, Switzerland, Mendrisio Ticino 6850, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Polichem SA (Owner Number: 10036234)

Owner / Operator Contact Address

Via Angelo Maspoli 11, Mendrisio, CH-TI 6850, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083087

PMA Number

N/A

All Registered Proprietary Names

Genadur

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2011-04-25

Official Correspondent

Francesc Binefa

US Agent Details

Barry Sands Business: Regulatory/Quality Management Information Source, Inc. Email: fdaadminsupport@rqmis.com Phone: (978) 8345701

Related Public Records

Same Entity

Polichem SA

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 3005427465. Last updated year: 2026. Please use registration number 3005427465 when referencing this establishment in official correspondence.