PRODUKT SERVICE ERDT GMBH

FDA Device Registration & Listing · Viernheim Hesse, DE · Registration 3013496958

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
3013496958
FEI Number
3013496958
Entity Name
PRODUKT SERVICE ERDT GMBH
City/State/Country
Viernheim Hesse, DE
Establishment Address
Fritz-Haber-Str. 6, Viernheim Hesse 68519, DE
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Produkt Service Erdt GmbH (Owner Number: 10052296)
Owner / Operator Contact Address
Fritz-Haber-Strasse 6, Viernheim, DE-HE 68519, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MagNA Pure 96 DNA and Viral NA SV Kit MagNA Pure 96 External Lysis Buffer MagNA Pure 96 DNA and Viral NA LV Kit MagNA Pure 96 Bacterial Lysis Buffer MagNA Pure 96 DNA Tissue Lysis Buffer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2018-02-02

Official Correspondent

Torsten Kuehlwein

US Agent Details

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

Related Public Records

Same Entity

Produkt Service Erdt GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013496958. Last updated year: 2026. Please use registration number 3013496958 when referencing this establishment in official correspondence.
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