Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011310668

FEI Number

3011310668

Entity Name

AN LANH INVESTMENT AND TRADING COMPANY LIMITED

City/State/Country

Thanh Nam Ward Ninh Binh, VN

Establishment Address

Lot 52, 53, 54, N3 Street, An Xa Industrial Park,, Thanh Nam Ward Ninh Binh NONE, VN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

AN LANH INVESTMENT AND TRADING COMPANY LIMITED (Owner Number: 10060675)

Owner / Operator Contact Address

Lot 52, 53, 54, N3 Street, An Xa Industrial Park,, Thanh Nam Ward,, VN-18 NONE, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-Rebreathing Mask Personal protection kit Anesthesia Mask Alcohol soaked cotton Shoe Cover Cotton swabs for testing, Cotton swabs for fluid collection Gauze / sponge,nonresorbable for external use View All GENEREL ORTHOPAEDIC PACK Antiseptic tape, adhesive tape, heat test, nose bleed pad Laryngeal Mask Airway AN 95 surgical mask LAB COAT Nebulizer Mask Medical face mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2021-12-06
PXC	Personal Protection Kit	General Hospital	Class 1	880.6250	2020-05-25
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2021-12-06
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-12-06
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2019-06-10
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-05-25
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-12-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-06-10
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2022-12-19
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-11-20
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-12-06
QKY	Decontamination Systems For N95 Respirators	Unknown	Class N	N/A	2020-12-10
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-02-28
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2021-12-06
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-25

Official Correspondent

DUNG NGUYEN

US Agent Details

Oliver Farnsworth Richard William Business: GLOBAL INSPECTION AND CERTIFICATION NETWORK (CGLOBAL) CORP Email: Oski30@icloud.com Phone: (716) 4034085

Related Public Records

Same Entity

AN LANH INVESTMENT AND TRADING COMPANY LIMITED

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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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.

Similar Registrations

Registration Number	Establishment Name	Location
3017923969	ANIBA HEALTH SOLUTIONS LLC.	Great Neck, NY, US
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
9710391	POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.	XIAMEN Fujian, CN
9611500	Draegerwerk AG & Co. KGaA	LUEBECK Schleswig-Holstein, DE
3005460813	TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD	Taizhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011310668. Last updated year: 2026. Please use registration number 3011310668 when referencing this establishment in official correspondence.