Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015277818

FEI Number

3015277818

Entity Name

HANGZHOU WEIZE IMP & EXP CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

1-1-1001, No.364 Xiangshan(Xiangshan Building), Zhuantang Street, Xihu District, Hangzhou Zhejiang 310024, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HANGZHOU WEIZE IMP & EXP CO., LTD (Owner Number: 10059980)

Owner / Operator Contact Address

1-1-1001, No.364 Xiangshan(Xiangshan Building), Zhuantang Street, Xihu District,, Hangzhou City, CN-ZJ 310024, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

hip band/ hip resistance bands /Sling shot hip circle CPAP Heating Tube/CPAP Tube/Ventilator heating tube Nasal washer, Nasal irrigator, Nasal Aspirator, Nasal cleaner, Nasal cleaning syringes, Electric nasal aspirator band aid / adhesive band aid / wound dressing / adhesive lumbar traction belt / non-adhering pads bandage / non-woven bandage / self adhesive bandage surgical tape/ muscle tape / sport tape / surgical tape Tube cover/mask cover/Mask Head Gear restraint straps/Restrainers/restraint holder Baby medicine feeder, Medicine syringe pacifier, Baby medicine pacifier, Baby feeder, Baby medicine applicator arm sling / arm brace/ forearm splint Nasal Cannula, Oxygen Cannula, Suction Catheter, Yankauer Suction Tip, Catheter, Tracheal Suction Catheter, Suction Tube, Suction Connecting Tube, Y-Suction Connector, Tubing Collection Cup, Urine Specimen Cup, Urine Plastic Container, Cuvette Cup, Sample Storage Specimen Vial Cup Goalkeeper Gloves / Goalie Gloves / glove / sport gloves kneepad / knee guard / knee brace Peri Bottle, Feminine Wash Bottle, Personal Hygiene Bottle, Sitz Bath Bottle, Vaginal Cleansing Bottle, Postpartum Bottle, Intimate Wash Bottle, Bidet Bottle Eye patch, Eye care pad, Eye sticker cane / stick / crutches / elbow crutch/ blind cane knee orthosis / adjustable knee orthosis / rom knee brace elbow support / elbow brace / arm support / arm sleeve Pelvic bra, Pelvic band, Pelvic belt, Pelvic girdle, Extenders, Pantyliners shoulder support / shoulder brace Wipes, Wet wipes, Moist towelette, Moist towel ankle guard / ankle support / ankle splint medical compression socks / compression stockings socks / sport socks / show socks / long socks/ pantyhose / compression socks cervical collar / emergency cervical collar / soft cervical collar / foam collar / neck brace lumbar traction belt / lumbar traction device neck traction device / cervical traction device /cervical collar / neck hammock/head hammock Vaginal suppository applicator/Applicator/Cosmetic syringe applicators/Syringe feeder VWELL MaxComfort Vaginal Applicator bite block / mouthpiece Gauze pad, Gauze roll, Cotton roll abduction pillow / abduction orthosis shoulder abduction orthosis lumbar support belt / lumbar support orthosis/ back support belt / waist support belt sweet sweat waist belt /waist trimmer belt /slimming waist belt Back stretcher/Lumbar stretcher/Back massage stretcher Ear washer, Ear irrigator, Ear cleane, Ear cleaning syringes, Marie Originals Ear Washer tourniquet / Single use tourniquet / disposable tourniquet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2019-03-17
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2020-11-05
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2023-07-10
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-03-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-03-17
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2019-12-21
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-07-10
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2019-03-17
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-12-30
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2023-07-10
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-03-17
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-12-30
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-12-29
IPS	Cane	Physical Medicine	Class 1	890.3075	2019-03-17
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2019-03-17
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2019-03-17
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2024-12-29
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2019-03-17
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-12-29
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-03-17
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2019-03-17
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2019-03-17
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2020-11-05
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2019-03-17
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-12-29
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2019-03-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-03-17
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2025-12-30
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2019-03-17

Official Correspondent

Tonson Tang

US Agent Details

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

Related Public Records

Same Entity

HANGZHOU WEIZE IMP & EXP 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-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015277818. Last updated year: 2026. Please use registration number 3015277818 when referencing this establishment in official correspondence.