Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009155880

FEI Number

3009155880

Entity Name

VASTRADE MANUFACTURING CORPORATION

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 26, Tongfuyu Industrial Zone, Longtian Community, Longtian Street, PingShan District, Shenzhen Guangdong 518100, CN

Establishment Type(s)

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

Owner / Operator

Vastrade Manufacturing Corporation (Owner Number: 10036268)

Owner / Operator Contact Address

Building 26, Tongfuyu Industrial Zone, Longtian Community, Longtian Street, PingShan District, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dressing, wound, occlusive FIBER, MEDICAL, ABSORBENT Device, Acupressure PILLBOX / PILL PLANNER DETECTORS AND REMOVERS, LICE, (INCLUDING COMBS) Pack, hot or cold, reusable SYRINGE, ENT Face Shield Shield, eye, ophthalmic Gauze / sponge,nonresorbable JOINT, ANKLE, EXTERNAL BRACE MASSAGER SPOON, EAR Oto Scoop OTOSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2011-04-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2013-05-07
MVV	Device, Acupressure	Unknown	Class U	N/A	2020-02-24
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2019-08-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-04-27
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2018-11-15
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-02-22
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2018-11-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-05-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-02-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-11-15
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2014-07-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-04-27
JZE	Spoon, Ear	Ear, Nose, Throat	Class 1	874.4420	2018-11-15
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2015-04-03

Official Correspondent

Ken Kan

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Vastrade Manufacturing 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009155880. Last updated year: 2026. Please use registration number 3009155880 when referencing this establishment in official correspondence.