Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013839458

FEI Number

3013839458

Entity Name

NINGBO HIGH-TECH BLUESKY MANUFACTORY AND TRADING CO.,LTD.

City/State/Country

NINGBO Zhejiang, CN

Establishment Address

3RD FLOOR, BUILDING B2, 959 CREATIVE PARK, CHENGXIN ROAD 959, NINGBO Zhejiang 315042, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device

Owner / Operator

Ningbo High-Tech Bluesky Manufactory and Trading Co.,Ltd. (Owner Number: 10059779)

Owner / Operator Contact Address

RM201, BUILDING B, HONGTAI PLAZA, NO.55 HAIYAN NORTH RD,, ningbo CHINA, Ningbo, CN-ZJ 315042, 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
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2019-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Ningbo High-Tech Bluesky Manufactory and Trading 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013839458. Last updated year: 2026. Please use registration number 3013839458 when referencing this establishment in official correspondence.