Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015341499

FEI Number

3015341499

Entity Name

Weihai Kangzheng Medical Equipments Technology Co.,Ltd

City/State/Country

weihai Shandong, CN

Establishment Address

Western Zone Sunjiatan Village, Yangting Town, weihai Shandong 264200, CN

Establishment Type(s)

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

Owner / Operator

Weihai Kangzheng Medical Equipments Technology Co.,Ltd (Owner Number: 10060176)

Owner / Operator Contact Address

Western Zone Sunjiatan Village,Yangting Town, weihai, CN-SD 264200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDICAL ADHESIVE TAPE STRIPS Disposable sterile swab Sterile Dressing SOLUTION, COPPER SULFATE FOR SPECIFIC GRAVITY DETERMINATIONS AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) Wound Skin Closure Kit DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) Wound Skin Closure TB-14 Disposable skin surface closure device KFH140 Wound Skin Closure TB-16 Wound Skin Closure TB-1 Disposable skin surface closure device KFH215 Wound Skin Closure TB-9 Disposable skin surface closure device KFH245 Disposable skin surface closure device KFH230 Disposable skin surface closure device KFH275 Disposable skin surface closure device KFH155 Wound Skin Closure TB-12 Disposable skin surface closure device KFH80 Disposable skin surface closure device KFH50 Wound Skin Closure TB-13 Disposable skin surface closure device KFH500 Wound Skin Closure TB-2 Disposable skin surface closure device KFH290 Wound Skin Closure TB-10 Disposable skin surface closure device KFH125 Wound Skin Closure TB-17 Wound Skin Closure TB-6 Wound Skin Closure TB-20 Disposable skin surface closure device KFH445 Disposable skin surface closure device KFH260 Disposable skin surface closure device KFH65 Wound Skin Closure TB-4 Disposable skin surface closure device KFH200 Wound Skin Closure TB-15 Wound Skin Closure TB-19 Wound Skin Closure TB-8 Disposable skin surface closure device KFH410 Disposable skin surface closure device KFH170 Wound Skin Closure TB-7 Wound Skin Closure TB-3 Wound Skin Closure TB-5 Disposable skin surface closure device KFH110 Disposable skin surface closure device KFH185 Wound Skin Closure TB-18 Disposable skin surface closure device KFH95 Wound Skin Closure TB-11 FYE / DRESS, SURGICAL Dye-indicator, pH (urinary, non-quantitative) Silicone Dressing,model:G3516,G3517,G3518,G3519,G3520,G3521,G3522,G3523,G3524,G3525,G3526,G3527,G3528,G3529,G3530 Silicone Dressing,model:G3501,G3502,G3503,G3504,G3505,G3506,G3507,G3508,G3509,G3510,G3511,G3512,G3513,G3514,G3515 Silicone Dressing,model:G3531,G3532 DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) Follicle-stimulating hormone test strips MEDICAL ICE PACK-Pre-cooled-A220,A250,A280,A300,A350,A400,A450,A500,A600,A700,A800,A900,A1000 MEDICAL ICE PACK-Pre-cooled-D220,D250,D280,D300,D350,D400,D450,D500,D600,D700,D800,D900,D1000 MEDICAL ICE PACK-Self-cooled-C250,C280,C300,C350,C400,C450,C500,C600,C700,C800,C900,C1000 MEDICAL ICE PACK-Pre-cooled-B250,B280,B300,B350,B400,B450,B500,B600,B700,B800,B900,B1000 MEDICAL ICE PACK-Pre-cooled-B50,B60,B70,B80,B90,B100,B110,B120,B130,B150,B180,B200,B220 MEDICAL ICE PACK-Self-cooled-D50,D60,D70,D80,D90,D100,D110,D120,D130,D150,D180,D200 MEDICAL ICE PACK-Pre-cooled-A50,A60,A70,A80,A90,A100,A110,A120,A130,A150,A180,A200 MEDICAL ICE PACK-Pre-cooled-C50,C60,C70,C80,C90,C100,C110,C120,C130,C150,C180,C200,C220 MEDICAL ICE PACK-Self-cooled-D220,D250,D280,D300,D350,D400,D450,D500,D600,D700,D800,D900,D1000 MEDICAL ICE PACK-Pre-cooled-D50,D60,D70,D80,D90,D100,D110,D120,D130,D150,D180,D200 MEDICAL ICE PACK-Pre-cooled-C250,C280,C300,C350,C400,C450,C500,C600,C700,C800,C900,C1000 MEDICAL ICE PACK-Self-cooled-A220,A250,A280,A300,A350,A400,A450,A500,A600,A700,A800,A900,A1000 Antipruritic Patch-32*120mm MEDICAL ICE PACK-Self-cooled-B50,B60,B70,B80,B90,B100,B110,B120,B130,B150,B180,B200,B220 MEDICAL ICE PACK-Self-cooled-A50,A60,A70,A80,A90,A100,A110,A120,A130,A150,A180,A200 MEDICAL ICE PACK-Self-cooled-C50,C60,C70,C80,C90,C100,C110,C120,C130,C150,C180,C200,C220 MEDICAL ICE PACK-Self-cooled-B250,B280,B300,B350,B400,B450,B500,B600,B700,B800,B900,B1000 First aid kit without drug ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC) KQO / AUTOMATED URINALYSIS SYSTEM Alcohol Wipe LH owulation test CEP / RADIOIMMUNOASSAY, LUTEINIZING HORMONE Disposbale Swab Tape and bandage, adhesive, adjustable closing mechanism, OTC use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-01-25
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2025-12-03
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-03
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Hematology	Class 1	864.9320	2019-04-08
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2019-04-08
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2025-12-03
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2019-04-08
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2023-06-27
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-04-08
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2019-04-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-05-28
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2019-04-08
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-09-24
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2019-04-08
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2025-12-03
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2019-04-08
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2019-04-08
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-12-03
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2019-04-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2025-12-03
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2019-04-08

Official Correspondent

Nicky Liu

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Weihai Kangzheng Medical Equipments Technology 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 3015341499. Last updated year: 2026. Please use registration number 3015341499 when referencing this establishment in official correspondence.