Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016171961

FEI Number

3016171961

Entity Name

HANGZHOU ALLINE PLASTIC CO., LTD.

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

(NORTH OF LOUSHIQIAO VILLAGE ) YUSHI ROAD, YUNHE STREET, YUHANG DISTRICT, HANGZHOU Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device,Remanufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device

Owner / Operator

Hangzhou Alline Plastic Co., Ltd. (Owner Number: 10061647)

Owner / Operator Contact Address

(NORTH OF LOUSHIQIAO VILLAGE ) YUSHI ROAD, YUNHE STREET, YUHANG DISTRICT, 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

Surgical Tray Wrap SHOE COVER Wheel Chair Cushion Hook, Tracheal - Tracheal Hook disposable medical mask Mattress Cover Tracheal Tube Fixation Device SHOE COVER, BOOT COVER Bandage, Elastic - Elastic Bandage Sponge And Gauze For External Use Gait Belt Civil masks CATHETER HOLDER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-07-19
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-04-18
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2019-11-06
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2019-11-06
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-30
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2019-11-06
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2019-11-06
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-04-18
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-11-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-11-06
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2019-11-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-04-16
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2020-04-18

Official Correspondent

QIAN YANG

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Alline Plastic 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
1037577	ANGIOSYSTEMS, INC.	DUCKTOWN, TN, US
3007485169	MEDYSSEY CO., LTD.	Jecheon-si Chungbuk, KR
3008489813	WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD	Weihai Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016171961. Last updated year: 2026. Please use registration number 3016171961 when referencing this establishment in official correspondence.