FDA Registration Active 🇨🇱 Chile

Industria Optica Rodenstock Chile S. A

Reg #: 3004848970 · FEI: 3004848970 · Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5

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Registration Details

Registration Name
Industria Optica Rodenstock Chile S. A
Registration Number
3004848970
FEI Number
3004848970
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Avenida Beaucheff N 1581 Santiago
City
Santiago , Region Metropolitana
Country
CL

Regulatory Submissions

510(k) Number
K202221

Owner / Operator

Firm Name
Rodenstock GmbHElsenheimer
Operator Number
10061326
Address
Elsenheimer Strasse 33
City
Munich
State
Bavaria
Postal Code
80687
Country
DE

US Agent

Business Name
Registrar Corp
Contact Name
David Lennarz
Address
144 Research Dr
City
Hampton
State
VA
ZIP
23666
Country
US
Phone
757 2240177 ext. 200

Products

Device Name Product Code
Tonometer, Ac-Powered HKX
Camera, Ophthalmic, Ac-Powered HKI
Sunglasses (Non-Prescription Including Photosensitive) HQY
Lens, Spectacle, Non-Custom (Prescription) HQG
Frame, Spectacle HQZ

Proprietary Names

DNEye Scanner 3 (HKI) DNEye Scanner 2 DNEye Scanner 2+ VX120 VX118 Porche Design Sunglasses Rodenstock Sunglasses Porsche Design Sunglasses

Establishment Types

Export Device to the United States But Perform No Other Operation on Device