Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003761281

FEI Number

3003761281

Entity Name

BERLINGER SPECIAL AG

City/State/Country

Ganterschwil Sankt Gallen, CH

Establishment Address

Mitteldorfstrasse 2, Ganterschwil Sankt Gallen 9608, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Berlinger Special AG (Owner Number: 10059907)

Owner / Operator Contact Address

Mitteldorfstrasse 2, Ganterschwil, CH-SG 9608, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BEREG-Kit small Blood Sample Container BEREG-Kit small single Blood Sample Container BEREG-Kit Urine Sample Container Berlinger Urine Collection Vessel BEREG-Kit Plastic full set BEREG-Kit small 2 containers BREG-Kit Plastic single set BEREG-Kit small single BEREG-Kit full set BEREG-Kit small 3 containers BEREG-Kit single set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2019-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

M. Jason Brooke Business: Brooke Consulting, LLC Email: jason@brooke-consulting.com Phone: (202) 2581422

Related Public Records

Same Entity

Berlinger Special AG

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 3003761281. Last updated year: 2026. Please use registration number 3003761281 when referencing this establishment in official correspondence.