Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016500342

FEI Number

3016500342

Entity Name

AdaptDx, Inc

City/State/Country

Middletown, PA, US

Establishment Address

1000 Kreider Drive, STE 700, Middletown, PA 17057, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

OpZira, Inc. (Owner Number: 10093974)

Owner / Operator Contact Address

1000 Kreider Drive, STE 700, Middletown, PA 17057, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AdaptDx Pro AdaptDx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUM	Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation	Ophthalmic	Class 1	886.1050	2025-08-27

Official Correspondent

Lori Holder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OpZira, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004174467	DIOPSYS INC.	Middletown, PA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016500342. Last updated year: 2026. Please use registration number 3016500342 when referencing this establishment in official correspondence.