Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017448136

FEI Number

3017448136

Entity Name

ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

No.599 Haijing Rd., Longgang City, Wenzhou City, Wenzhou Zhejiang 325802, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang Ailebao Medical Technology Co., Ltd (Owner Number: 10076832)

Owner / Operator Contact Address

No.599 Haijing Rd, Longgang,, 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

skin closures Silicone Scar Sheet Silicone Wound Dressing Silicone Tape Silicone Sheeting Sterile Wound Dressing Hydrocolloid Dressing transparent Film Dressing Sterile Hydrocolloid Dressing Sterile foam dressing Bag, Drainage, with Adhesive, Ostomy-Ostomy bags Bag, Urine collection, Leg, For external use, Sterile-Urine collection Bags Spot Acne Patch Blister Plaster Surgical Film Silicone Foam Dressing Anti-leakage Strip, Hydrocolloid skin barrier, Hydrocolloid Skin Protective Ring, Belt, Skin Protective Paste Skin Protective Powder, protective dressing wipe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2022-03-30
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-03-30
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-03-30
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-07-31
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2020-07-31
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-03-30
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-04-01

Official Correspondent

Chunsheng Sheng

US Agent Details

Mukesh Kumar Business: Brij Strategic Consultations, LLC Email: mkumar@FDAMap.com Phone: (240) 7504893

Related Public Records

Same Entity

Zhejiang Ailebao Medical Technology 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

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 3017448136. Last updated year: 2026. Please use registration number 3017448136 when referencing this establishment in official correspondence.