Sun Diagnostics, LLC

FDA Device Registration & Listing · New Gloucester, ME, US · Registration 3009672007

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
3009672007
FEI Number
3009672007
Entity Name
Sun Diagnostics, LLC
City/State/Country
New Gloucester, ME, US
Establishment Address
60 Pineland Drive, Brunswick Hall, Suite 322, New Gloucester, ME 04260, US
Establishment Type(s)
Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Sun Diagnostics, LLC (Owner Number: 10041112)
Owner / Operator Contact Address
60 Pineland Drive, Brunswick Hall, Suite 322, New Gloucester, ME 04260, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Insulated Lockbox Insert SunDx Lp(a)-P ELISA SunDx Rapid Biotin Assay - BTN n/a

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2026-03-16
OTR Research Use Only/Immunology Devices Unknown Class N N/A 2015-05-07
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2014-04-16

Official Correspondent

Rae-Anne Nguyen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sun Diagnostics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009672007. Last updated year: 2026. Please use registration number 3009672007 when referencing this establishment in official correspondence.
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