Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009308084

FEI Number

3009308084

Entity Name

BIVIAX GMBH & CO KG

City/State/Country

Dortmund North Rhine-Westphalia, DE

Establishment Address

Hagener Strasse 428, Dortmund North Rhine-Westphalia 44229, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

biviax GmbH & Co KG (Owner Number: 10037830)

Owner / Operator Contact Address

Hagener Strasse 428, Dortmund, DE-NW 44229, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

K-Tape K-Tape My Skin CROSSTAPE K-Tape Pure Pre K Gel K-Scissors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2011-08-23
KOY	Degreaser, Skin, Surgical	General, Plastic Surgery	Class 1	878.4730	2012-05-16
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2012-05-16

Official Correspondent

Ingo Kumbrink

US Agent Details

Clemens W. Pauly Business: Pauly P.A. Email: pauly@cpauly.com Phone: (305) 9676900

Related Public Records

Same Entity

biviax GmbH & Co KG

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 3009308084. Last updated year: 2026. Please use registration number 3009308084 when referencing this establishment in official correspondence.