Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007327603

FEI Number

3007327603

Entity Name

BANDEX INDUSTRIAL CORP.

City/State/Country

Zhuhai City Guangdong, CN

Establishment Address

No.1, Chuangye West Road, Shuanglinpianqu, Liangang Industrial Park, Jinwan District, Zhuhai City Guangdong 519045, CN

Establishment Type(s)

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

Owner / Operator

Bandex Industrial Corp. (Owner Number: 10027300)

Owner / Operator Contact Address

No.1,Chuangye West Road, Shuanglinpianqu, Liangang Industrial Park,Jinwan District, Zhuhai City, CN-GD 519045, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dressing, wound, occlusive pick, massaging Tape and bandage, adhesive Nitrile Gloves UNIT, ULTRAVIOLET SANITATION/STERILIZATION (FOR TOOTHBRUSHES), NON-STERILE Cotton applicators BANDAGE, ELASTIC Cotton applicators Nitrile Gloves, Scissors

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	2008-10-22
JET	Pick, Massaging	Dental	Class 1	872.6650	2024-12-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2008-10-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-10-25
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-10-25
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2024-12-02
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-09-27
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2008-10-22
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-09-27
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2023-09-20

Official Correspondent

C. Chen

US Agent Details

Ingrid Liao Business: Fleet Link, Inc Email: ingrid@fleetlinkinc.us Phone: (508) 2791500

Related Public Records

Same Entity

Bandex Industrial Corp.

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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
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

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 3007327603. Last updated year: 2026. Please use registration number 3007327603 when referencing this establishment in official correspondence.