Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003393069

FEI Number

3003393069

Entity Name

BIOANALYTIC GMBH

City/State/Country

Umkirch/Freiburg Baden-Wurttemberg, DE

Establishment Address

Waldmatten 10-13, Umkirch/Freiburg Baden-Wurttemberg 79224, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bioanalytic GmbH (Owner Number: 10030817)

Owner / Operator Contact Address

Waldmatten 10-13, Umkirch/Freiburg, DE-BW 79224, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thrombopur Thrombo-TIC Eos-TIC Leuko-TIC SF Reti-TIC LeukoCount Leukopur EosCount Leuko-TIC Sperm-TIC ThromboCount Leuko-TIC VT Erypur EryCount Ery-TIC TIC Capillary Pack 10µl TIC Capillary Pack 20µl TIC Capillary Pack 5µl Bryopette Osmolality Calibration Standard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCG	Fluid, Diluting, Manual Cell	Hematology	Class 1	864.8200	2009-11-18
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2010-01-13
JMZ	Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality	Clinical Chemistry	Class 1	862.1540	2018-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: FDAbasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Bioanalytic 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 3003393069. Last updated year: 2026. Please use registration number 3003393069 when referencing this establishment in official correspondence.