Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031590640

FEI Number

3031590640

Entity Name

Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.

City/State/Country

shenzhen Guangdong, CN

Establishment Address

Building 302, Kampar Chuang Industrial Park, Building 9A, Xinsha wuxiang, biling community, Biling Street, Pingshan District, shenzhen Guangdong 518118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd (Owner Number: 10090805)

Owner / Operator Contact Address

Room 301, Building A, Jinbaochuang Industrial Park, No. 9, Xinsha 5th Lane, Biling Community, Biling Street,, Pingshan District,, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anti-Parainfluenza Viruses test kit RM Flu A&B/MP Antigen detection test kit(3in1) Drainaqe bac HCVTest Strip ( Serum/Plasma/WVholeBlood) Syphilis Rapid Test Strip (Serum/Plasma/WholeBlood DISPOSABLE NITRILE EXAMINATION GLOVES DISPOSABLE VINYL/NITRILE BLEND GLOVES Disposable PE Gloves Disposable sampling swab Medical isolation mask/Disposable PE Gloves Mycoplasma pneumonia AntigenRapid Test Cassette COVID-19 antigen detection kit HIV 1/2/0 Test Strip (Serum/Plasma/WholeBlood) BsAg Test Serip( Serum/Plasma/WholeBlood) Medical bandages,Protective bandage Disposable virus sampling tube denovirus antigen rapid detection kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2024-05-16
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2024-05-16
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-05-16
MJY	Kit, Serological, Negative Control	Clinical Chemistry	Class 1	862.1660	2024-08-16
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-02-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-02-22
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2026-02-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-02-22
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-05-16
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2024-05-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-05-16
GSB	Antigens, Cf, All, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2024-05-16
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	2024-08-16
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-05-16
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-05-16
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2024-05-16

Official Correspondent

Wenlong Zhang

US Agent Details

Peter Yang Business: Jiamei consulting inc Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

Minlong Pharmaceutical Biotechnology (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
K780273	Flow Laboratories, Inc.	INFLUENZA HI PRESERUM	1978-02-28
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

Similar Registrations

Registration Number	Establishment Name	Location
1528450	Ortho-Clinical Diagnostics, Inc.	ATHENS, OH, US
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
3003750284	REMEL EUROPE LTD	DARTFORD, KENT, GB
3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031590640. Last updated year: 2026. Please use registration number 3031590640 when referencing this establishment in official correspondence.