Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011805315

FEI Number

3011805315

Entity Name

ZHEJIANG AICOR MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Linhai Zhejiang, CN

Establishment Address

999 Linshan Road, Baishuiyang Town, Linhai Zhejiang 317031, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhejiang Aicor Medical Technology Co., Ltd. (Owner Number: 10049633)

Owner / Operator Contact Address

999 Linshan Road, Baishuiyang Town, Linhai, CN-ZJ 317031, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Urine Tube Medline Bulb Syringe 50ML and 60ML

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-12-01
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-08-25
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2015-07-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-05-16

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@Simconintl.Com Phone: (847) 9492290

Related Public Records

Same Entity

Zhejiang Aicor Medical Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011805315. Last updated year: 2026. Please use registration number 3011805315 when referencing this establishment in official correspondence.