Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026045952

FEI Number

3026045952

Entity Name

SOLVEMED INC.

City/State/Country

Lewes, DE, US

Establishment Address

16192 Coastal Highway, Sussex, Lewes, DE 19958, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Solvemed Inc. (Owner Number: 10086513)

Owner / Operator Contact Address

16192 Coastal Highway, Lewes, DE 19958, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PuRe Pupillometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2022-11-15

Official Correspondent

Michal Wlodarski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solvemed Inc.

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 3026045952. Last updated year: 2026. Please use registration number 3026045952 when referencing this establishment in official correspondence.