Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003843927

FEI Number

3003843927

Entity Name

Vitrolife GmbH

City/State/Country

Landshut Bavaria, DE

Establishment Address

Roedersteinstrasse 6, Landshut Bavaria 84034, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vitrolife GmbH (Owner Number: 9087379)

Owner / Operator Contact Address

Roedersteinstrasse, 6, Landshut, DE-NOTA 84034, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192008

PMA Number

N/A

All Registered Proprietary Names

Octax LaserShotM Octax NaviLase

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRX	System, Assisted Reproduction Laser	Obstetrics/Gynecology	Class 2	884.6200	2020-04-06

Official Correspondent

SUSANNE SCHWEITZER

US Agent Details

Erin Schardt Business: Vitrolife Inc. Email: eschardt@vitrolife.com Phone: (303) 7621933

Related Public Records

Same Entity

Vitrolife GmbH

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 3003843927. Last updated year: 2026. Please use registration number 3003843927 when referencing this establishment in official correspondence.