Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012391162

FEI Number

3012391162

Entity Name

Qingdao Likangyuan Medical Device Co.,Ltd.

City/State/Country

Qingdao Shandong, CN

Establishment Address

No.257 Leigongshan Road,Huangdao, Qingdao Shandong 266423, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Qingdao Likangyuan Medical Device Co.,Ltd. (Owner Number: 10050240)

Owner / Operator Contact Address

No.257 Leigongshan Road,Huangdao, Qingdao, CN-SD 266423, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dressing, wound, hydrophilic BANDAGE, ELASTIC ACCESSORY, SURGICAL APPAREL MASK, SCAVENGING Dressing, wound, occlusive lsolation gown, protective overall, medical protective clothing Gauze / sponge,nonresorbable for external use O.R towel Disposable OR Towels

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2021-05-19
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2015-10-23
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-10-23
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-29
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2024-03-26
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-07
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-04-01
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2021-05-19
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-03-26
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-29
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-10-23
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-01-06

Official Correspondent

Jingli Dong

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Qingdao Likangyuan 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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 3012391162. Last updated year: 2026. Please use registration number 3012391162 when referencing this establishment in official correspondence.