Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008044603

FEI Number

3008044603

Entity Name

ZHEJIANG AOKI MEDICAL DRESSING CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

No.2066 Qiyuan Road, Longgang City, Wenzhou Zhejiang 325802, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

ZHEJIANG AOKI MEDICAL DRESSING CO., LTD (Owner Number: 10030859)

Owner / Operator Contact Address

No.2066 Qiyuan Road, Longgang City, Wenzhou, CN-ZJ 325802, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAFF, Alcohol pad Transparent Dressing Hydrocolloid Dressing Tourniquet Foam dressing,type G3 Wound Dressing Ice Pack SURGICAL dressing Face mask, Flat type/Folding type Medical cotton bud Medical cotton ball Alcohol prep pad Povidone-Iodine prep pad Alginate dressing, type D3 X-ray Dressing chitin dressing Hydrocolloid dressings,type G1 Hydrogel Dressing Medical surgical incise drapes Sterile Pad Clean Wipes Medical Povidone-Iodine surgical incise drapes Medical surgical drapes series Antiseptic Wipes aoki, Silicone Dressings, Model silicone dressing type Surgical Adhesive Tape Scissor Tweezer Safety Pins Cooling paste First aid kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-01-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2009-11-19
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2009-11-19
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2009-11-19
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-11-19
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2009-11-19
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2009-11-19
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2009-11-19
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2018-11-09
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-11-19
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2009-11-19
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2009-11-19

Official Correspondent

Weiyan Pan

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

ZHEJIANG AOKI MEDICAL DRESSING 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
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 3008044603. Last updated year: 2026. Please use registration number 3008044603 when referencing this establishment in official correspondence.