ZOLLNER ELECTRONICS GMBH

FDA Device Registration & Listing · Hombrechtikon Zurich, CH · Registration 3010594620

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
3010594620
FEI Number
3010594620
Entity Name
ZOLLNER ELECTRONICS GMBH
City/State/Country
Hombrechtikon Zurich, CH
Establishment Address
Garstligweg 2, Hombrechtikon Zurich 8634, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Zollner Electronics GmbH (Owner Number: 10045311)
Owner / Operator Contact Address
Manfred-Zollner-Str. 1, Zandt, DE-BY 93499, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EasyOne Air QIAsymphony SP QIAcube EasyOne Pro/Pro LAB

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2019-11-06
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2013-11-05
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2013-11-05
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2021-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

Azfar Jafri Business: Zollner Electronics Inc Email: azfar_jafri@zollner-electronics.com Phone: (408) 3829828

Related Public Records

Same Entity

Zollner Electronics GmbH
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
K923989 Sensor Medics Corp. SENSORMEDICS MODEL 6200 AUTOBOX DL 1993-08-09
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010594620. Last updated year: 2026. Please use registration number 3010594620 when referencing this establishment in official correspondence.
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