Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008825965

FEI Number

3008825965

Entity Name

XIAMEN BOSON BIOTECH CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

90-94 Tianfeng Road, Jimei North Industry Park, Xiamen Fujian 361021, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Boson Biotech Co., Ltd. (Owner Number: 10046875)

Owner / Operator Contact Address

90-94 Tianfeng Road, Jimei North Industry Park, Xiamen, CN-FJ 361021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2020-11-13
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2020-11-13
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2020-11-13
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2020-11-13

Official Correspondent

Chang-Gong Zhang

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Xiamen Boson Biotech 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-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008825965. Last updated year: 2026. Please use registration number 3008825965 when referencing this establishment in official correspondence.