STRATO s.r.l.

FDA Device Registration & Listing · SETTEVILLE Belluno, IT · Registration 3001033549

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
3001033549
FEI Number
3001033549
Entity Name
STRATO s.r.l.
City/State/Country
SETTEVILLE Belluno, IT
Establishment Address
ZONA ARTIGIANALE, 3/C, SETTEVILLE Belluno 32038, IT
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STRATO s.r.l. (Owner Number: 10053096)
Owner / Operator Contact Address
ZONA ARTIGIANALE, 3/C, SETTEVILLE, IT-BL 32038, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQZ Frame, Spectacle Ophthalmic Class 1 886.5842 2016-10-31
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2017-12-14

Official Correspondent

CAMILLA STRAMARE

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

STRATO s.r.l.
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
K910951 United Optical, Spa OPTHLAMIC FRAMES 1991-05-06
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001033549. Last updated year: 2026. Please use registration number 3001033549 when referencing this establishment in official correspondence.
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