HELMER Inc.

FDA Device Registration & Listing · NOBLESVILLE, IN, US · Registration 3004973569

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
3004973569
FEI Number
3004973569
Entity Name
HELMER Inc.
City/State/Country
NOBLESVILLE, IN, US
Establishment Address
14400 Bergen Blvd, NOBLESVILLE, IN 46060, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
HELMER INC. (Owner Number: 2182537)
Owner / Operator Contact Address
14400 BERGEN BLVD., --, Noblesville, IN 46060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Helmer Plasma Storage Freezer Helmer Blood Storage Refrigerator HELMER PLATELET INCUBATOR PLASMA THAWING SYSTEM Laboratory and Pharmacy Refrigerator and Freezer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSE Refrigerator, Freezer, Blood Storage Hematology Class 2 864.9700 2000-12-04
KSH Chamber, Environmental For The Storage Of Platelet Concentrate Hematology Class 2 864.9575 2004-09-08
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2004-09-08

Official Correspondent

RENEE SCHULTZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HELMER 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-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004973569. Last updated year: 2026. Please use registration number 3004973569 when referencing this establishment in official correspondence.
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