Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710020

FEI Number

3003340795

Entity Name

ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD.

City/State/Country

HUZHOU Zhejiang, CN

Establishment Address

Building 1-2, No. 588 Dragon King Creek Middle Road, Dipu Street, ANJI COUNTY, HUZHOU Zhejiang 313300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Anji Huabu Industrial Co., Ltd. (Owner Number: 9045080)

Owner / Operator Contact Address

Building 1-2, No. 588 Dragon King Creek Middle Road, Dipu Street, Anji County, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Plaster of Paris Bandage Nebulizer Chamber with Mask, Nebulizer with Mask and Tubbing Self-Adhesive Bandage Urine Bag wooden applicator with Cotton Wooden Applicator without Cotton Ear Ulcer Syringe DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC petrolatum gauze Combination Water Bottle, Hot Water Bag, Ice Bag Rubber Oval Nasal Oxygen Cannula Elastic Bandage Stockinette Roll Plastic Cotton Swabs, Wooden Applicator with Single Cotton Orthopedic Casting Splint Disposable medical mask (non-sterile) Medical isolation eye mask Medical isolation mask Tubular Bandage/Stockinette Vaginal Douche 150ml Mucus Extractor Circular Air Cushion Orthopedic Casting Tape/Bandage CAST (MULTIPLE BRANDS) Male Catheter Vaseline Gauze Urine Bag for Legs, Urine Bag Pediatric, Urine Bag Pear Shape with Drainage Tube Medical protective clothing Medical isolation suit Suction Catheter, Nelaton Catheter Irrigation Syringe with/without bulb

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2016-12-12
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2016-12-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-12-12
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2016-12-03
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2016-12-03
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-12-03
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2017-05-26
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2016-12-03
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2016-12-03
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2001-03-13
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2016-12-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2016-12-03
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-12-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-24
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2016-12-12
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2016-12-03
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2016-12-03
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2016-12-03
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2001-04-16
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2016-12-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-05-26
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2016-12-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-26
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2016-12-03
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-12-03

Official Correspondent

Lu Zhili

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Zhejiang Anji Huabu Industrial 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
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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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 9710020. Last updated year: 2026. Please use registration number 9710020 when referencing this establishment in official correspondence.