Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007766685

FEI Number

3007766685

Entity Name

Microtek Computer Technology (Wu Jiang) Co, Ltd.

City/State/Country

SuZhou Jiangsu, CN

Establishment Address

No.499,JiangXing East Road, WuJiang Economic and Technological Development Zone, SuZhou Jiangsu 215217, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Microtek International, Inc. (Owner Number: 10029311)

Owner / Operator Contact Address

No.6, Industry East Road 3, Science-Based Industrial Park, Hsinchu, TW-HSZ 30075, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091288

PMA Number

N/A

All Registered Proprietary Names

Medi-6000 Plus AF Medi-2200 Plus MSS-600XU2LG Medi-6000 Plus Medi-7000 MSS-600XU2L MSS-600XU2LT M700 Medi-7000 Ultra Medi-6000 Ultra MII-700 Ultra M7000 Ultra MICROTEK MII-600 Ultra M6000 Ultra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMA	Digitizer, Image, Radiological	Radiology	Class 2	892.2030	2009-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

Microtek International, Inc.

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 3007766685. Last updated year: 2026. Please use registration number 3007766685 when referencing this establishment in official correspondence.