Rodenstock GmbH

FDA Device Registration & Listing · Munich Bavaria, DE · Registration 3010069263

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
3010069263
FEI Number
3010069263
Entity Name
Rodenstock GmbH
City/State/Country
Munich Bavaria, DE
Establishment Address
Elsenheimer Strasse 33, Munich Bavaria 80687, DE
Establishment Type(s)
Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Rodenstock Gmbh (Owner Number: 9055622)
Owner / Operator Contact Address
Elsenheimer Strasse 33, Munich, DE-NOTA 80687, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Rodenstock DNEye Scanner 2+, DNEye Scanner 2 , VX120, VX118

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2012-11-13
HQG Lens, Spectacle, Non-Custom (Prescription) Ophthalmic Class 1 886.5844 2003-03-27
HQZ Frame, Spectacle Ophthalmic Class 1 886.5842 2012-11-13
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2018-02-23
HOI Spectacle, Magnifying Ophthalmic Class 1 886.5840 2012-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Rodenstock Gmbh
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K940726 Jay-Y Enterprises Co., Inc. NONE-GENERIC 1994-04-11
K934837 Simon Marketing, Inc. SUNGLASSES 1993-12-08
K852902 Yours Enterprise Co., Ltd. METALLIC SUNGLASSES 1985-08-12
K970895 Custom Optical Frames, Inc. CUSTOM OPTICAL SUNGLASS FRAMES 1997-05-06
K853921 Winsburn Company , Ltd. ALL KINDS OF SUNGLASSES 1985-10-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010069263. Last updated year: 2026. Please use registration number 3010069263 when referencing this establishment in official correspondence.
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