Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010595009

FEI Number

3010595009

Entity Name

Anhui Kangfu Industrial Foreign Trade Co.,Ltd

City/State/Country

Tianchang Anhui, CN

Establishment Address

East Huayuan Road, Chajian Industrial Park, Tianchang Anhui 239321, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Anhui Kangfu Industrial Foreign Trade Co., Ltd (Owner Number: 10045337)

Owner / Operator Contact Address

East Huayuan Road, Chajian Industrial Park, Tianchang, CN-AH 239321, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instant Hot Pack, Instant Cold Pack, Frozen Ice Pack Non-woven shoe cover Tape, Adhesive Tape, Adhesive Bandage, Athletic Tape, Kinesiology Tape JOINT, ANKLE, EXTERNAL BRACE ANKLE SUPPORT, ANKLE STABILIZER Support, Arm Medical Support, Support, Ankle/Knee/Elbow/Wrist/Waist/Arm/Shoulder, Support, Pouch JOINT, KNEE, EXTERNAL BRACE, KNEE SUPPORT, KNEN STABILIZER Glove, Calf, Orthosis Non-woven Pad, Gauze Pad, Compression Pad, Burn Dressing, Surgical Dressing First-aid kit SPLINT, HAND, AND COMPONENTS, WRIST SUPPORT WRIST SPLINT, FINGER SPLINT HAND SUPPPORT General scavenging mask General Mask Elastic Bandage, Stretch Bandage, Triangular Bandage Non-woven Caps Disposable Surgical Caps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-12-04
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2015-11-30
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-07-09
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-04-01
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-05-27
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-04-01
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-01-09
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-12-04
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2015-11-30
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-04-01
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-27
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-11-07
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-11-30

Official Correspondent

Jin Zhao

US Agent Details

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

Related Public Records

Same Entity

Anhui Kangfu Industrial Foreign Trade 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
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-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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.

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3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010595009. Last updated year: 2026. Please use registration number 3010595009 when referencing this establishment in official correspondence.