Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010160459

FEI Number

3010160459

Entity Name

Tecan Software Competence Center GmbH

City/State/Country

Mainz-Kastel Rhineland-Palatinate, DE

Establishment Address

Peter-Sander-Strasse 41a, Mainz-Kastel Rhineland-Palatinate 55252, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Tecan Group AG (Owner Number: 9050992)

Owner / Operator Contact Address

103 Seestrasse, --, Maennedorf, CH-ZH 8708, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Freedom EVO 75 : Freedom EVO : Freedom EVOlyzer : Genesis FE 500 : Freedom EVO Clinical : Fluent AVENIO Edge System AcfS Detection Robot AcfS Library Robot Veya Dx AcfS L&D Equipment Installation Bundle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTV	Research Use Only/Clinical Chemistry Devices	Unknown	Class N	N/A	2017-12-15
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2001-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

Taunya Alexander Business: Tecan U.S. Email: regulatory.affairs.us@tecan.net Phone: (919) 5725421

Related Public Records

Same Entity

Tecan Group AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003559191	Tecan Trading AG	Maennedorf Zurich, CH
3003402518	TECAN SCHWEIZ AG	MAENNEDORF ZUERICH Zurich, CH
9710337	IBL INTERNATIONAL GMBH	HAMBURG, DE
3002710220	TECAN AUSTRIA GMBH	GROEDIG Salzburg, AT
3003537036	TECAN CDMO SOLUTIONS MH, CORP.	MORGAN HILL, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Similar Registrations

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3003742580	DNA GENOTEK, INC.	Ottawa Ontario, CA
8022032	SOUTHMEDIC, INC.	BARRIE Ontario, CA
1721937	CORGENIX, INC.	BROOMFIELD, CO, US
2182595	DIASORIN INC.	Stillwater, MN, US
3003559191	Tecan Trading AG	Maennedorf Zurich, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010160459. Last updated year: 2026. Please use registration number 3010160459 when referencing this establishment in official correspondence.