HAMILTON BONADUZ AG

FDA Device Registration & Listing · BONADUZ Graubunden, CH · Registration 8030996

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8030996
FEI Number
3001421318
Entity Name
HAMILTON BONADUZ AG
City/State/Country
BONADUZ Graubunden, CH
Establishment Address
VIA CRUSCH 8, BONADUZ Graubunden 7402, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HAMILTON BONADUZ AG (Owner Number: 8030996)
Owner / Operator Contact Address
VIA CRUSCH 8, --, BONADUZ, CH-NOTA 7402, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

cobas prime Tip rack tray cobas prime Universal Tray cobas prime Secondary Tube AltoStar Automation System AM16 Microlab STAR, Microlab STARlet ELITE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2014-11-26
JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use Clinical Chemistry Class 1 862.2150 2013-02-05

Official Correspondent

No official correspondent registered.

US Agent Details

Tim Zavora Business: Director of Quality Assurance Email: Tim.Zavora@hamiltoncompany.com Phone: (775) 4516566

Related Public Records

Same Entity

HAMILTON BONADUZ AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K760211 Instrumentation Laboratory CO ANALYZER, GLUCOSE/UREA/CREATININE 1976-08-26

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030996. Last updated year: 2026. Please use registration number 8030996 when referencing this establishment in official correspondence.
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