Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010806467

FEI Number

3010806467

Entity Name

UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.

City/State/Country

ShenZhen Guangdong, CN

Establishment Address

101, 201, 301, Bldg 38,Xialang Industrial Area,Heshuikou,, Matian Street, Guangming District, ShenZhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Unimicro Medical Systems (Shenzhen) Co., Ltd. (Owner Number: 10046262)

Owner / Operator Contact Address

101, 201, 301, Bldg 38,Xialang Industrial Area,Heshuikou, Matian Street,Guangming District, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150068

PMA Number

N/A

All Registered Proprietary Names

Trocar Kit ATR Series, BTR Series, VTR Series, HTR Series, STR Series, UNTR Series, UNTB Series, 1TR Series Auto Retrieval Pouch Insufflation Tubing Set Veress Needle MND11200, MND11500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-10-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-12-01
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2014-09-02
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2015-10-15
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2015-10-15

Official Correspondent

Xinfeng Chen

US Agent Details

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

Related Public Records

Same Entity

Unimicro Medical Systems (Shenzhen) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K141593	Unimicro Medical Systems (Shenzhen) Co., Ltd.	UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH	2014-11-13
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010806467. Last updated year: 2026. Please use registration number 3010806467 when referencing this establishment in official correspondence.