Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008751375

FEI Number

3008751375

Entity Name

PHARMAZEUTISCHE FABRIK MONTAVIT GES.M.B.H.

City/State/Country

Absam Tirol, AT

Establishment Address

Salzbergstrasse 96, Absam Tirol 6067, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Pharmazeutische Fabrik Montavit Ges.m.b.H. (Owner Number: 10056924)

Owner / Operator Contact Address

Salzbergstrasse 96, Absam, AT-7 6067, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cathejell S Safergel Sterile Ultrasound Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FHX	Jelly, Lubricating, For Transurethral Surgical Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-01-30
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2023-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Pharmazeutische Fabrik Montavit Ges.m.b.H.

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 3008751375. Last updated year: 2026. Please use registration number 3008751375 when referencing this establishment in official correspondence.