OP COUTURE BRILLEN GMBH

FDA Device Registration & Listing · PASSAU Bavaria, DE · Registration 3001429093

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
3001429093
FEI Number
3001429093
Entity Name
OP COUTURE BRILLEN GMBH
City/State/Country
PASSAU Bavaria, DE
Establishment Address
Spitalhofstr. 94, PASSAU Bavaria 94032, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
OP COUTURE BRILLEN GMBH (Owner Number: 9048911)
Owner / Operator Contact Address
Spitalhofstrasse 94, --, PASSAU, DE-BY 94032, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CAZAL Sunglasses

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 2001-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Ugur Ulusoy Business: Palm Optical Email: chris.phillips@ultrapalm.com Phone: (347) 8317902

Related Public Records

Same Entity

OP COUTURE BRILLEN 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 3001429093. Last updated year: 2026. Please use registration number 3001429093 when referencing this establishment in official correspondence.
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