Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016970619

FEI Number

3016970619

Entity Name

QUANG NAM MEDICAL DEVICES FACTORY BRANCH OF DANAMECO MEDICAL JOINT STOCK CORPORATION

City/State/Country

Dien Ban Bac Ward Da Nang, VN

Establishment Address

Trang Nhat 2 Industrial Cluster,, Dien Ban Bac Ward Da Nang NONE, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DANAMECO MEDICAL JOINT STOCK CORPORATION (Owner Number: 10071934)

Owner / Operator Contact Address

No 12 Trinh Cong Son Street,, Hoa Cuong Ward, VN-DN NONE, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tammy Face Care D-Care Medical face mask D-Care Ophthalmology Pack D-Care Foot wrap D-Care Mask scavenging D-Care Urology Pack Tammy Face Care D-Care Surgical gown Surgical gown with accessories Labcoat Surgical gown kit Angiography set Danameco Surgical Cap (head cover) Danameco Non-Woven Surgical Caps Surgical Cap Bouffant cap D-Care Antistatic shoe cover D-Care ENT Pack D-care Hospital bed accessories Liquid skin protectant D-Care Danameco Absorbent tipped applicator Medical Swab Cotton Buds Cardiology Speciality Pack Universal Laparotomy Pack Anal Pack D-Care Epidural Anaesthesia Pack Gynecolory Pack Orthopedic Pack Drape Neurology Pack Small Universal Pack Obstetrics pack General Surgical Pack D-Care Adhesive surgical film D-Care Elastic Bandage D-Care Medical plastic bag Disposable plastic sheet Examination Gown D-Care D-Care Elastic Tape; Adhesive Bandage D-Care Elastic compression bandages Elastic compression belt D-Care Medical cotton Cotton ball D-care Non-woven surgical gauze Dental Gauze Drainage Gauze Meche gauze Non-woven meche gauze Triangle gauze Laparotomy Sponge; Surgical gauze Surgical gauze kit Eye bangdge kit D-Care Surgical shoes D-Care Drape, pure latex sheet D-Care Disposable Apron Danameco Medical absorbent fiber Underpad Cotton and gauze pack Wound dressing cotton Gauze ball Brain surgery dressing Non-woven fabric wound dressing FAV injection kit Baby Wipe Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2020-04-24
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2021-07-15
OTX	Foot Wrap For Treating Restless Leg Syndrome Symptoms	Physical Medicine	Class 1	890.5760	2021-07-15
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-05-27
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2021-07-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-24
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-10-08
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-05-27
ERY	Drape, Surgical, Ent	General, Plastic Surgery	Class 2	878.4370	2021-07-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-03-22
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2021-07-26
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-10-08
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-07-15
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2021-07-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2021-07-15
HMW	Drape, Microscope, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2021-07-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2021-07-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-07-15
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2021-07-15
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-07-15
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2021-04-21
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-05-27
EYX	Drape, Pure Latex Sheet, With Self-Retaining Finger Cot	General, Plastic Surgery	Class 2	878.4370	2021-07-15
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-07-15
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-10-08

Official Correspondent

Nguyen Dinh Phuong Nam

US Agent Details

Oliver Farnsworth Richard William Business: GLOBAL INSPECTION AND CERTIFICATION NETWORK LLC (CGLOBAL) Email: Oski30@icloud.com Phone: (864) 4034085

Related Public Records

Same Entity

DANAMECO MEDICAL JOINT STOCK CORPORATION

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016970619. Last updated year: 2026. Please use registration number 3016970619 when referencing this establishment in official correspondence.