LUMACLEAN, LLC

FDA Device Registration & Listing · Concord, NC, US · Registration 3027514586

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
3027514586
FEI Number
3027514586
Entity Name
LUMACLEAN, LLC
City/State/Country
Concord, NC, US
Establishment Address
9724 Colts Neck Lane, Concord, NC 28027, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
LumaClean, LLc (Owner Number: 10090702)
Owner / Operator Contact Address
9724 Colts Neck Lane, Concord, NC 28027, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

StomaEase

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2024-04-30

Official Correspondent

Martin von Dyck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LumaClean, 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-0013-2012 Convatec Inc. 1
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027514586. Last updated year: 2026. Please use registration number 3027514586 when referencing this establishment in official correspondence.
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