Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020034

FEI Number

3008238542

Entity Name

ANITA Dr. Helbig GMBH (Austria)

City/State/Country

KUFSTEIN Tirol, AT

Establishment Address

ENDACH 40, KUFSTEIN Tirol 6332, AT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Anita Dr. Helbig GMBH (Owner Number: 8020034)

Owner / Operator Contact Address

Endach 40, Kufstein, AT-7 6332, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anita

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCZ	Prosthesis, Breast, External, Used With Adhesive	General, Plastic Surgery	Class 1	878.3800	1985-04-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Anita Dr. Helbig GMBH

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

View Entity Profile →

Similar Registrations

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3023855650	NANNING SIXTANT BIOTECHNOLOGY CO., LTD	Nanning Guangxi, CN
3004134970	AMERICAN BREAST CARE LP	Marietta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020034. Last updated year: 2026. Please use registration number 8020034 when referencing this establishment in official correspondence.