Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009749957

FEI Number

3009749957

Entity Name

BIOCER ENTWICKLUNGS-GMBH

City/State/Country

Bayreuth Bavaria, DE

Establishment Address

Ludwig-Thoma-Strasse 36c, Bayreuth Bavaria 95447, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioCer Entwicklungs-GmbH (Owner Number: 10041544)

Owner / Operator Contact Address

Ludwig-Thoma-Strasse 36c, Bayreuth, DE-BY 95447, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113311

PMA Number

N/A

All Registered Proprietary Names

Ti02Mesh¿

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2012-08-03
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2012-08-03

Official Correspondent

Jasmin Richter

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

BioCer Entwicklungs-GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009749957. Last updated year: 2026. Please use registration number 3009749957 when referencing this establishment in official correspondence.