Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003402518

FEI Number

3003402518

Entity Name

TECAN SCHWEIZ AG

City/State/Country

MAENNEDORF ZUERICH Zurich, CH

Establishment Address

103 SEESTRASSE, MAENNEDORF ZUERICH Zurich 8708, CH

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

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 EVOlyzer Freedom EVOlyzer PROFI BLOT 48-2in1 PROFI BLOT T48 PROFI BLOT 48 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
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2005-02-22
QBZ	Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma	Clinical Chemistry	Class 1	862.2750	2019-11-15
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2012-04-25
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2018-03-12
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2016-03-08
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2008-01-17
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2012-12-12
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2018-03-12
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2005-02-23
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2021-07-02
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2021-07-03
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
3010160459	Tecan Software Competence Center GmbH	Mainz-Kastel Rhineland-Palatinate, DE
3003559191	Tecan Trading AG	Maennedorf 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
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
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-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003402518. Last updated year: 2026. Please use registration number 3003402518 when referencing this establishment in official correspondence.