Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007028040

FEI Number

3007028040

Entity Name

ZHEJIANG TOP-MEDICAL MEDICAL DRESSING CO.,LTD.

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

No. 633, 2 Jinhai Road , Economic and Technological Development Zone, WENZHOU Zhejiang 325025, CN

Establishment Type(s)

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

Owner / Operator

ZHEJIANG TOP-MEDICAL MEDICAL DRESSING CO.,LTD. (Owner Number: 9097008)

Owner / Operator Contact Address

No. 633, 2 Jinhai Road , Economic and Technological Development Zone, Wenzhou, CN-ZJ 325025, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrogel dressing Alginate Dressing Foam Dressing Alginate Dressing (Gel Type) Alginate Dressing (Powder Type) Hydrocolloid Dressing TRANSPARENT DRESSING Hydrocolloid Dressing, AFD01 (5CM*5CM) Hydrocolloid Dressing, AFD30 (5CM*5CM) Adhesive Dressing Nonwoven Wound Dressing Hydrocolloid Foam Dressing Silicone Dressing POINTMASS Hydrocolloid Acne patch(Transparent, Large area absorption)-PM-YDAP03 POINTMASS Hydrocolloid Acne patch(Star shaped patch, Colorful)-PM-YDAP04 POINTMASS Hydrocolloid Dressing, PMH01022(10*10CM) POINTMASS Hydrocolloid Acne Patch (Transparent, Invisible)-PM-YDAP11 POINTMASS Hydrocolloid Dressing, PMH01011(10*10CM) POINTMASS Hydrocolloid Dressing, PMH0101(10*10CM) POINTMASS Silicone Dressing, PMS0101 (10*10CM) POINTMASS Hydrocolloid Acne Patch (Star shaped patch, Colorful)-PM-YDAP14 POINTMASS Silicone Dressing, PMS0102 (10*10CM) Acne Patch POINTMASS Transparent Dressing, PMT0101 (10cm*12CM) POINTMASS Hydrocolloid Acne patch (Transparent, Invisible)-PM-YDAP01 POINTMASS Hydrocolloid Dressing, PMH0102(10*10CM) POINTMASS Hydrocolloid Acne patch (Transparent, Increase absorption)-PM-YDAP02 POINTMASS Transparent Dressing, PMT0102 (15cm*20CM) POINTMASS Silicone Dressing, PMSS01(17.5cm*17.5CM) STERI-STRIP SURGICAL TAPE ADHESIVE TAPES SKIN CLOSURES Adhesive Silicone Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2009-03-25
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-10-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-01-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

ZHEJIANG TOP-MEDICAL 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
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

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 3007028040. Last updated year: 2026. Please use registration number 3007028040 when referencing this establishment in official correspondence.