Roche Diabetes Care GmbH

FDA Device Registration & Listing · Mannheim Baden-Wurttemberg, DE · Registration 3011806823

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
3011806823
FEI Number
3011806823
Entity Name
Roche Diabetes Care GmbH
City/State/Country
Mannheim Baden-Wurttemberg, DE
Establishment Address
Sandhofer Strasse 116, Mannheim Baden-Wurttemberg 68305, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Roche Diagnostics Operations Inc. (Owner Number: 9039767)
Owner / Operator Contact Address
9115 Hague Road, Indianapolis, IN 46250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080227
PMA Number
N/A

All Registered Proprietary Names

Accu-Chek Softclix Blood Lancing System ACCU-CHEK 360 DIABETES MGMT 2.3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-08-31
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-08-31
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2010-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Roche Diagnostics Operations Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010900203 Roche Diagnostics S.L. Sant Cugat del Valles Barcelona, ES
3039321686 Roche Lumira Dx Stirling Manor Loan Stirling, GB
3039322300 Roche Lumira Dx Bathgate Bathgate Scotland, GB
3020917535 Roche Diagnostics (Suzhou) Ltd. Suzhou Jiangsu, CN
3011393376 ROCHE DIABETES CARE, INC. Indianapolis, IN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011806823. Last updated year: 2026. Please use registration number 3011806823 when referencing this establishment in official correspondence.
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