Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022596459

FEI Number

3022596459

Entity Name

HENAN MAIDINGKANG MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Changyuan Henan, CN

Establishment Address

Shuangchuangyuan Industrial Zone, Dingluan Town, Changyuan Henan 453412, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Henan Maidingkang Medical Technology Co., Ltd. (Owner Number: 10084915)

Owner / Operator Contact Address

Shuangchuangyuan Industrial Zone, Dingluan Town, Changyuan, CN-HA 453412, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silicone Tape Non woven island dressing Ostomy pouch Hydrocolloid Heel patch HYDROCOLLOIDBLISTER PLASTER and ACNE DOTS MEDICAL-GRADEHYDROCOLLOID ROLL,HYDROCOLLOID BLISTER PLASTER,HYDROCOLLOID ACNE DOT PATCH Hydrocolloid Dressing PU membrane (model: MDK-PUMS-01-01, MDK-PUMS-01-02, MDK-PUMS-01-03, MDK-PUMS-01-04, MDK-PUMS-01-05, MDK-PUMS-01-06) Transparent film PU membrane (model: MDK-PUMS-01-19, MDK-PUMS-01-20) PU membrane (model: MDK-PUMS-01-07, MDK-PUMS-01-08, MDK-PUMS-01-09, MDK-PUMS-01-10, MDK-PUMS-01-11, MDK-PUMS-01-12) PU membrane (model: MDK-PUMS-01-13, MDK-PUMS-01-14, MDK-PUMS-01-15, MDK-PUMS-01-16, MDK-PUMS-01-17, MDK-PUMS-01-18) Scar sticker

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	2022-04-14
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2022-04-14
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-04-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-04-14
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2022-04-14
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-04-14

Official Correspondent

Lei Xiong

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Henan Maidingkang Medical 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.

Similar Registrations

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3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022596459. Last updated year: 2026. Please use registration number 3022596459 when referencing this establishment in official correspondence.