Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011559089

FEI Number

3011559089

Entity Name

Auckland Medical Polymer (Tianjin) Co., Ltd

City/State/Country

Tianjin, CN

Establishment Address

Bldg D5-2 XEDA International Industrial Park, Xiqing Economic Development Area, Tianjin 300385, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Auckland Medical Polymer (Tianjin) Co., Ltd (Owner Number: 10048110)

Owner / Operator Contact Address

15 Feihong Rd, Nankai Dist, Tianjin, CN-TJ 300372, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183148

PMA Number

N/A

All Registered Proprietary Names

OKLand Disposable Face Shield OKLand Gel Pads OKLand Adjustable Stirrups for Lithotomy Surgery OKLand Protective Goggle OKLand Patient Return Electrode Pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-16
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2014-12-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2015-12-22
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-02-25

Official Correspondent

Ying Zhang

US Agent Details

Hai Wu Email: 15122456760@163.com Phone: (714) 7845202

Related Public Records

Same Entity

Auckland Medical Polymer (Tianjin) 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011559089. Last updated year: 2026. Please use registration number 3011559089 when referencing this establishment in official correspondence.