KEM ENTERPRISES,INC.

FDA Device Registration & Listing · Ada, MI, US · Registration 1835573

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
1835573
FEI Number
3001452083
Entity Name
KEM ENTERPRISES,INC.
City/State/Country
Ada, MI, US
Establishment Address
579 Roundtree Dr NE, Ada, MI 49301, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KEM ENTERPRISES, INC. (Owner Number: 9031708)
Owner / Operator Contact Address
579 Roundtree Dr. NE, Ada, MI 49301, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OSTO-EZ-VENT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 1997-09-26

Official Correspondent

Aaron James

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KEM ENTERPRISES, INC.
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 1835573. Last updated year: 2026. Please use registration number 1835573 when referencing this establishment in official correspondence.
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