NINGBO SKYEY INDUSTRY & TRADE CO.LTD

FDA Device Registration & Listing · Ningbo Zhejiang, CN · Registration 3027507876

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
3027507876
FEI Number
3027507876
Entity Name
NINGBO SKYEY INDUSTRY & TRADE CO.LTD
City/State/Country
Ningbo Zhejiang, CN
Establishment Address
NO.515 Kangzhuang South Road, Ningbo Zhejiang 315032, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Ningbo Skyey Industry & Trade Co.Ltd (Owner Number: 10087871)
Owner / Operator Contact Address
NO.515 Kangzhuang South Road, Ningbo, CN-ZJ 315032, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Elbow brace, Arm supports Ankle brace Thumb brace Back braces Knee brace 01, Knee brace 02, Knee brace 03 Foot arch supports

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IOY Support, Arm Physical Medicine Class 1 890.3475 2025-06-08
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2025-06-08
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2025-06-08
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2025-06-08
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2023-04-24
OHI Orthosis, Foot Drop Physical Medicine Class 1 890.3475 2025-06-08

Official Correspondent

Bojing Gu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Ningbo Skyey Industry & Trade Co.Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027507876. Last updated year: 2026. Please use registration number 3027507876 when referencing this establishment in official correspondence.
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