Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005064943

FEI Number

3005064943

Entity Name

BELLAIRE INDUSTRY

City/State/Country

MIDDLE ISLAND, NY, US

Establishment Address

11 Heather Ct, MIDDLE ISLAND, NY 11953, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

BELLAIRE INDUSTRY (Owner Number: 9071294)

Owner / Operator Contact Address

11 HEATHER COURT, --, Middle Island, NY 11953, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243143

PMA Number

N/A

All Registered Proprietary Names

needle, aspiration and injection, disposable - CJN Needle Cartridge E-pen (e-pen)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2026-03-09
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2026-03-09

Official Correspondent

SING-HONG YEUNG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BELLAIRE INDUSTRY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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2030580	Tulip Medical Products, Inc.	San Diego, CA, US
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
3030839824	HANGZHOU ENDO MEDICAL INSTRUMENT CO.,LTD	hangzhou Zhejiang, CN
3005528784	Ambler Surgical, LLC	EXTON, PA, US
3022748632	TAURUS Medizintechnik GmbH	Fridingen an der Donau Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005064943. Last updated year: 2026. Please use registration number 3005064943 when referencing this establishment in official correspondence.