BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC.

FDA Device Registration & Listing · Peachtree Corners, GA, US · Registration 1067143

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1067143
FEI Number
3003750694
Entity Name
BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC.
City/State/Country
Peachtree Corners, GA, US
Establishment Address
2975 Gateway Dr, Peachtree Corners, GA 30071, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BioCure Solutions, LLC dba BioCure, Inc. (Owner Number: 10093191)
Owner / Operator Contact Address
2975 Gateway Dr, Peachtree Corners, GA 30071, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Belzer UW® Cold Storage Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2025-04-14
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2025-04-14

Official Correspondent

Minh Vo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioCure Solutions, LLC dba BioCure, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

Similar Registrations

Registration Number Establishment Name Location
3011421726 Marizyme, Inc. West Palm Bch, FL, US
3024820181 INSTITUT GEORGES LOPEZ ST LAURENT DE CHAMOUSSET Rhone, FR
3020224798 LIFECYCLE BIOTECHNOLOGIES, LLC Cleburne, TX, US
3031884833 Bridge to Life Ltd Duluth, GA, US
3010765841 INSTITUT GEORGES LOPEZ Lissieu Auvergne-Rhone-Alpes, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1067143. Last updated year: 2026. Please use registration number 1067143 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.