Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009566748

FEI Number

3009566748

Entity Name

NINGHAI LUOJIA ELECTRONICS SC., LTD

City/State/Country

NINGHAI, NINGBO Zhejiang, CN

Establishment Address

Binbei Road, Liyang Town, NINGHAI, NINGBO Zhejiang 315600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NINGHAI LUOJIA ELECTRONICS CO.,LTD (Owner Number: 10040451)

Owner / Operator Contact Address

Binbei Rd, Liyang Town, NINGHAI, NINGBO, CN-ZJ 315600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gumchucks Oralwise Protego nasal dilator O2 nasal dilator Breathwell Sleepwell GumChucks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2012-04-16
JES	Floss, Dental	Dental	Class 1	872.6390	2020-12-30

Official Correspondent

No official correspondent registered.

US Agent Details

michael doll Business: MLDOLL ENGINEERING Email: mldolleng@gmail.com Phone: (715) 3387971

Related Public Records

Same Entity

NINGHAI LUOJIA ELECTRONICS CO.,LTD

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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009566748. Last updated year: 2026. Please use registration number 3009566748 when referencing this establishment in official correspondence.