Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010453122

FEI Number

3010453122

Entity Name

NINGBO SUN-LITE INTERNATIONAL LTD.

City/State/Country

NINGBO Zhejiang, CN

Establishment Address

RM 1101, NORTH KIRIN MANSION,, NO1501,NORTH TIANTONG ROAD, NINGBO Zhejiang 315192, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ningbo Sun-Lite International Ltd. (Owner Number: 10043723)

Owner / Operator Contact Address

RM 1101, NORTH KIRIN MANSION,, NO1501,NORTH TIANTONG ROAD, NINGBO, CN-ZJ 315192, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2013-03-14

Official Correspondent

Xiaobing Ma

US Agent Details

James Schmitz Business: Innovative Innovations Inc Email: docjim.medschoolsupply@gmail.com Phone: (702) 6280164

Related Public Records

Same Entity

Ningbo Sun-Lite International 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010453122. Last updated year: 2026. Please use registration number 3010453122 when referencing this establishment in official correspondence.