Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006621348

FEI Number

3006621348

Entity Name

CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD.

City/State/Country

CHANGZHOU Jiangsu, CN

Establishment Address

1 BEIYANG ROAD, HEXI VILLAGE, ZOUQU TOWN, CHANGZHOU Jiangsu 213144, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD. (Owner Number: 9097066)

Owner / Operator Contact Address

NO. 30, BEI DA ST, ZHOUQU TOWN, --, CHANGZHOU, JIANGSU PROVINCE, CN-NOTA 213144, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Waist Guard; Athletic Guard; Back Guard Mouth Guard (Tooth protection) Sterile Hypodermic Syringes for Single Use Elbow Brace; Wrist Brace; Palm Guard First Aid Kit Gentell Blue Foam Dressing RTD Wound Dressing DermaBlue Foam CuraBlue Silver Foam Vitale RTD Wound Dressing Medical External Fixation Splint Finger Guard Shoulder Pad Leg Guard DRESSING OCCLUSIVE Foam Wound Dressing WOUND Face Mask, Face Shield, Eye Shield Medical Face Mask Disposable Face Mask Disposable Surgical Mask Hydrocolloid Dressing Sterile Eye Pad Head Guard; Neck Guard Eye Shield, Protective Goggles Knee Guard NECK STRAP /HEAD STRAP/ULTRA STRAP Chest Guard Non-woven Sugical Tape HYDROPHILIC DRESSING WOUND TAPE AND BANDAGE Elastic Tape Elastic Adhesive Bandage ADHESIVE Kinesio Tape First-aid case Kinesiology tape and Kinezio tape Sterile Gauze Sponges; Elbow Brace; Wrist Brace; Palm Guard; Ankle Support Stomal Bag Ostomy Pouch Arm Guard Elastic Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2018-11-13
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2018-11-13
PGO	Anti-Stick Glass Syringe	Unknown	Class N	N/A	2018-11-13
KFT	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical	Physical Medicine	Class 1	890.3420	2018-11-13
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2016-12-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-07-23
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2018-11-13
LQX	Device, Finger-Sucking	Physical Medicine	Class 1	890.3475	2018-11-13
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2018-11-13
OTX	Foot Wrap For Treating Restless Leg Syndrome Symptoms	Physical Medicine	Class 1	890.5760	2018-11-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-01-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-06
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	2020-04-08
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-07-23
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2018-11-13
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2018-11-13
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-05-06
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-11-13
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2018-11-13
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2018-11-13
FXN	Tape, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2020-02-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-01-25
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-01-25
KFX	Assembly, Thigh/Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2018-11-13
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	2018-10-28
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-11-13
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-10-28

Official Correspondent

No official correspondent registered.

US Agent Details

GANG Zhang Business: SILVER TEK Email: tony5683@comcast.net Phone: (610) 3536686

Related Public Records

Same Entity

CHANGZHOU MAJOR MEDICAL PRODUCTS 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006621348. Last updated year: 2026. Please use registration number 3006621348 when referencing this establishment in official correspondence.