Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027605742

FEI Number

3027605742

Entity Name

Xiamen Zhiyuan Medical Technology Co., Ltd.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

3RD Floor, No.208, SIMING PARK, XINMIN TOWN, TONG'AN DISTRICT, XIAMEN Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Zhiyuan Medical Technology Co.,Ltd (Owner Number: 10088289)

Owner / Operator Contact Address

3RD Floor, No.208, Siming Park, Xinmin Town, Tong'an District, Xiamen, CN-FJ 361100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

centrifuge tube Sample Collector RESIN, MATERIAL, Impression Tray Oropharyngeal airway pcr plate PCR buffer tube CONTAINER, SPECIMEN, NON-STERILE Disposable Medical Aerosol Mask Impression Tray Nebulizer Mask nasal aspirator nasal rinse nasal irrigation Cell culture Dish Cell culture Flask Cell culture Plate deep well plate, ELISA plate anesthesia face mask Bone Dust Trap Cryovial Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2023-06-25
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-06-25
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2023-06-25
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2023-06-25
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-06-25
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	2023-06-25
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2023-06-25
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2023-06-25
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2025-03-17
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2023-06-25
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2023-06-25
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2025-01-13
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2024-05-24

Official Correspondent

Meiyu Lv

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Xiamen Zhiyuan 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-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027605742. Last updated year: 2026. Please use registration number 3027605742 when referencing this establishment in official correspondence.