Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003041175

FEI Number

3003041175

Entity Name

WEIDMANN MEDICAL TECHNOLOGY AG

City/State/Country

Bad Ragaz Sankt Gallen, CH

Establishment Address

Industriestrasse 94-98, Bad Ragaz Sankt Gallen 7310, 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 Accu-Chek FastClix Blood Lancing System

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
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-06-07

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
3010874143	WEIDMANN MEDICAL TECHNOLOGY AG	Rapperswil 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 3003041175. Last updated year: 2026. Please use registration number 3003041175 when referencing this establishment in official correspondence.