SHANGHAI SINZEN MEDTECH LTD.

FDA Device Registration & Listing · Shanghai, CN · Registration 3042285123

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
3042285123
FEI Number
3042285123
Entity Name
SHANGHAI SINZEN MEDTECH LTD.
City/State/Country
Shanghai, CN
Establishment Address
5F,Tower B,ShangJi Information Building,No.1588,Lianhang Road,Minhang District, Shanghai 201112, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shanghai Sinzen Medtech Ltd. (Owner Number: 10094496)
Owner / Operator Contact Address
5F,Tower B,ShangJi Information Building,No.1588,Lianhang Road,Minhang District, Shanghai, CN-SH 201112, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SurRotate Precise Dissector SurRotate Precise Needle Holder SurRotate Maryland Dissector SurRotate Clinch Forceps SurRotate Fenestrated Forceps SurRotate Needle Holder

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-12-03

Official Correspondent

Zoe Li

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shanghai Sinzen Medtech 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 3042285123. Last updated year: 2026. Please use registration number 3042285123 when referencing this establishment in official correspondence.
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