Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035786168

FEI Number

3035786168

Entity Name

HANGZHOU R&L MEDICAL DEVICE CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

South of 1F and Room 302, 3F, Building 8, No. 8-5, Keji Road, Yuhang Street, Yuhang District, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou R&L Medical Device Co., Ltd (Owner Number: 10092371)

Owner / Operator Contact Address

Room 302, 3F, Building 8, No.8-5, Keji Road, Yuhang Street, Yuhang District, Hangzhou City,, Zhejiang Province, P.R. China, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrocolloid Acne Patch Visible Waterproof Polyurethane Foam Dressing Hydrocolloid Bandage Silicone Scar Gel Silicone Gel Sheet Hydrocolloid Adhesive Bandages Advanced Healing Waterproof Bandages

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	2024-12-30
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-12-30
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-12-30
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-12-30

Official Correspondent

Luming Sun

US Agent Details

Nelson Xie Email: nelson.xie@wiselinkus.com Phone: (631) 2558110

Related Public Records

Same Entity

Hangzhou R&L Medical Device 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 3035786168. Last updated year: 2026. Please use registration number 3035786168 when referencing this establishment in official correspondence.