Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680276

FEI Number

3010320336

Entity Name

CORTEX BIOPHYSIK GMBH

City/State/Country

LEIPZIG Saxony, DE

Establishment Address

Walter-Koehn-Str. 2d, LEIPZIG Saxony 04356, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CORTEX BIOPHYSIK GMBH (Owner Number: 9007843)

Owner / Operator Contact Address

WALTER-KOEHN-STR. 2d, --, LEIPZIG, DE-SN 04356, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001631

PMA Number

N/A

All Registered Proprietary Names

MetaSoft MetaLyzer 3B MetaSoft Studio MetaLyzer MetaMax 3B MetaSoft Studio MetaMax MetaSoft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2008-01-07
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2008-01-07

Official Correspondent

Daniel Postler

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc. Email: usagent@ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

CORTEX BIOPHYSIK 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 9680276. Last updated year: 2026. Please use registration number 9680276 when referencing this establishment in official correspondence.