Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002853327

FEI Number

3002853327

Entity Name

LICHTENHELDT GMBH

City/State/Country

Wahlstedt Schleswig-Holstein, DE

Establishment Address

Industriestr. 7 - 9, Wahlstedt Schleswig-Holstein 23812, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lichtenheldt GmbH (Owner Number: 10049808)

Owner / Operator Contact Address

Industriestr. 7 - 11, Wahlstedt, DE-SH 23812, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MagNa Pure 96 System Fluid Digital LightCycler Partitioning Fluid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2015-08-03

Official Correspondent

Holger Knobelspies

US Agent Details

Brian Frazier Business: Roche Diagnostics Operations Inc Email: brian.frazier@roche.com Phone: (317) 5214603

Related Public Records

Same Entity

Lichtenheldt GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011661720	TRUCKEE APPLIED GENOMICS INC	Reno, NV, US
3005504113	KEMENTEC SOLUTIONS AS	Taastrup Hovedstaden, DK
3005181013	TAKARA BIOTECHNOLOGY (DALIAN) CO., LTD.	Dalian Liaoning, CN
3006537286	AUTOBIO DIAGNOSTICS CO., LTD.	Zhengzhou Henan, CN
3036685103	REAGENT	Runcorn Cheshire West and Chester, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002853327. Last updated year: 2026. Please use registration number 3002853327 when referencing this establishment in official correspondence.