BLU-LAB LLC

FDA Device Registration & Listing · Carolina, PR, US · Registration 3015248743

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
3015248743
FEI Number
3015248743
Entity Name
BLU-LAB LLC
City/State/Country
Carolina, PR, US
Establishment Address
MONTECENTRO, 400 Calle Daguao A 402, Carolina, PR 00987, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
BLU-LAB LLC (Owner Number: 10095022)
Owner / Operator Contact Address
400 Calle Daguao A 402, MONTECENTRO, Carolina, PR 00987, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NJH KEK&CO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NJH Lens, Spectacle (Prescription), For Reading Discomfort Ophthalmic Class 1 886.5844 2026-02-05
HQZ Frame, Spectacle Ophthalmic Class 1 886.5842 2026-02-05

Official Correspondent

Rahuel Rodriguez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BLU-LAB LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K910951 United Optical, Spa OPTHLAMIC FRAMES 1991-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015248743. Last updated year: 2026. Please use registration number 3015248743 when referencing this establishment in official correspondence.
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