Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010874143

FEI Number

3010874143

Entity Name

WEIDMANN MEDICAL TECHNOLOGY AG

City/State/Country

Rapperswil Sankt Gallen, CH

Establishment Address

Neue Jonastrasse 60, Rapperswil Sankt Gallen 8640, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Weidmann Medical Technology AG (Owner Number: 10030580)

Owner / Operator Contact Address

Industriestrasse 96, Bad Ragaz, CH-SG 7310, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

cobas omni ProcessingPlate AssayCup tray Sealing Mats K-Tray Plate Deep Well 2.2ml Extraction plate 2 ml Extraction plate 1.6ml Tube-S Box of 12 x 24 Barcode Clip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-02-24

Official Correspondent

Jens Friedrich

US Agent Details

Jill O'Neal Business: Weidmann Electrical Technology Inc Email: jill.oneal@weidmann-group.com Phone: (937) 5082106

Related Public Records

Same Entity

Weidmann Medical Technology 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
3003041175	WEIDMANN MEDICAL TECHNOLOGY AG	Bad Ragaz Sankt Gallen, CH

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010874143. Last updated year: 2026. Please use registration number 3010874143 when referencing this establishment in official correspondence.