Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029906968

FEI Number

3029906968

Entity Name

OIVI AS

City/State/Country

Oslo, NO

Establishment Address

Gaustadalleen 21, Oslo 0349, NO

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Oivi AS (Owner Number: 10088795)

Owner / Operator Contact Address

Karenslyst Alle 16D, Oslo, NO-03 0278, NO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OFC100L, Oivi Fundus Camera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2023-10-11

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Oivi AS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029906968. Last updated year: 2026. Please use registration number 3029906968 when referencing this establishment in official correspondence.