Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011280379

FEI Number

3011280379

Entity Name

DONGGUAN CITY RISEN MEDICAL PRODUCTS CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.7 Chuangye Industrial Park, Jianshazhou, Dongguan Guangdong 523062, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DONGGUAN CITY RISEN MEDICAL PRODUCTS CO., LTD (Owner Number: 10048023)

Owner / Operator Contact Address

Room 301, Building 3, No.7, Wanjiang Chuangye Industrial Road, Wanjiang Street, Dongguan, CN-GD 523062, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DRESSING, COMPRESSION (DRESSING, COMPRESSION) CPR Mask First Aid Kit with drug (First Aid Kit with drug) MOUTHPIECE, BREATHING (CPR mask) TOURNIQUET, NONPNEUMATIC (TOURNIQUET, NONPNEUMATIC) Stethoscope Colostomy Bag Kaolin Hemostatic Gauze Chest Seal Decompression Needle SPLINT, TRACTION (SPLINT, TRACTION) First aid kit without drug (First Aid Kits)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2015-01-05
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2023-12-25
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2014-12-22
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2016-01-15
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2015-01-05
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2023-01-11
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2023-01-11
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-01-05
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-01-11
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-01-11
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2015-01-05
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2014-11-26

Official Correspondent

Lotus Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

DONGGUAN CITY RISEN 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

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 3011280379. Last updated year: 2026. Please use registration number 3011280379 when referencing this establishment in official correspondence.