NANOENTEK AMERICA, INC

FDA Device Registration & Listing · North Waltham, MA, US · Registration 3007113174

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
3007113174
FEI Number
3007113174
Entity Name
NANOENTEK AMERICA, INC
City/State/Country
North Waltham, MA, US
Establishment Address
220 Bear Hill Road Suite 102, North Waltham, MA 02451, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
NanoEntek, Inc (Owner Number: 10041714)
Owner / Operator Contact Address
220 Bear Hill Road Suite 102, Waltham, MA 02451, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

F10 FREND System FREND 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2025-12-15

Official Correspondent

Jacob Jung

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NanoEntek, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009092698 NANOENTEK INC Seoul, KR
3007349751 NANOENTEK INC Hwaseong Gyeonggi, KR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007113174. Last updated year: 2026. Please use registration number 3007113174 when referencing this establishment in official correspondence.
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