SHENZHEN TENGDA ZHICHUANG TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · shenzhen Guangdong, CN · Registration 3021314601

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
3021314601
FEI Number
3021314601
Entity Name
SHENZHEN TENGDA ZHICHUANG TECHNOLOGY CO., LTD.
City/State/Country
shenzhen Guangdong, CN
Establishment Address
B058, East & West Towers, Phase IV, Blue Coast, No. 1 Huaming Road, Yuehai Subdistrict, Nanshan District, shenzhen Guangdong 518000, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Shenzhen Tengda Zhichuang Technology Co., Ltd. (Owner Number: 10083467)
Owner / Operator Contact Address
B058, East & West Towers, Phase IV, Blue Coast, No. 1 Huaming Road, Yuehai Subdistrict, Nanshan District, Shenzhen, CN-GD 518000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CD9501B,CD9501A,CD9501C KN95 Mask,KN95

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Unknown Class N N/A 2021-11-22

Official Correspondent

Huang Dan

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Shenzhen Tengda Zhichuang Technology 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 3021314601. Last updated year: 2026. Please use registration number 3021314601 when referencing this establishment in official correspondence.
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