Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043861826

FEI Number

3043861826

Entity Name

RESTEC SOLUTIONS, LLC

City/State/Country

Chapel Hill, NC, US

Establishment Address

6350 Quadrangle Dr Ste 140, Chapel Hill, NC 27517, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RESTEC Solutions, LLC (Owner Number: 10086225)

Owner / Operator Contact Address

6350 Quadrangle Dr, Suite 140, Chapel Hill, NC 27517, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sonopro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2022-10-24

Official Correspondent

Paul Baumgartner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RESTEC Solutions, LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

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3018520804	ZHONGSHAN SUNCLEAN CO.,LTD	Zhongshan Guangdong, CN
8021896	ALBERT BROWNE LTD.	LEICESTER, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043861826. Last updated year: 2026. Please use registration number 3043861826 when referencing this establishment in official correspondence.