Shanghai Yunze Biotechnology Co., Ltd.

FDA Device Registration & Listing · Minhang Disctrict Shanghai, CN · Registration 3026848661

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
3026848661
FEI Number
3026848661
Entity Name
Shanghai Yunze Biotechnology Co., Ltd.
City/State/Country
Minhang Disctrict Shanghai, CN
Establishment Address
Room 301, 302-1, 401-1, Building 10, 760 Xinjun Ring Road, Minhang Disctrict Shanghai 201112, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shanghai Yunze Biotechnology Co., Ltd. (Owner Number: 10087388)
Owner / Operator Contact Address
Room 301, 302-1, 401-1, Building 10, 760 Xinjun Ring Road,, Minhang Disctrict, CN-SH 201112, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203833
PMA Number
N/A

All Registered Proprietary Names

PANABAY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MLM Enzyme Immunoassay, Tracrolimus Clinical Chemistry Class 2 862.1678 2023-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Shanghai Yunze Biotechnology Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026848661. Last updated year: 2026. Please use registration number 3026848661 when referencing this establishment in official correspondence.
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