Biomerics NLE

FDA Device Registration & Listing · Monroe, CT, US · Registration 3016079756

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
3016079756
FEI Number
3016079756
Entity Name
Biomerics NLE
City/State/Country
Monroe, CT, US
Establishment Address
246 Main St, Monroe, CT 06468, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Biomerics (Owner Number: 10042380)
Owner / Operator Contact Address
6030 W Harold Gatty Drive, Salt Lake City, UT 84116, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SP Obturator, Circular

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-11-25

Official Correspondent

Jacob Wakley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3026390991 Biomerics Dominican Republic Haina San Cristobal, DO
3014246639 Biomerics Cartago Cartago, CR
3012159165 BIOMERICS Advanced Catheter Brooklyn Park, MN, US
3008998256 BIOMERICS Salt Lake City, UT, US
3003678543 Biomerics Alajuela ALAJUELA, CR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016079756. Last updated year: 2026. Please use registration number 3016079756 when referencing this establishment in official correspondence.
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