Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007607706

FEI Number

3007607706

Entity Name

NANJING 3H MEDICAL PRODUCTS CO.,LTD.

City/State/Country

NANJING Jiangsu, CN

Establishment Address

No.1, No.5, Zhushan Road, Gaochun Economic Development Zone, NANJING Jiangsu 211300, CN

Establishment Type(s)

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

Owner / Operator

NANJING 3H MEDICAL PRODUCTS CO.,LTD. (Owner Number: 10027557)

Owner / Operator Contact Address

No.1, No.5, Zhushan Road, Gaochun Economic Development Zone, Nanjing, CN-JS 211300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

silicone gel foam dressing Pain Relief Patch Dressing, Compression Surgical mask (sterile) OKTAPE ADHESIVE TAPE MYOTAPE nasal breathing tape ice bag KIT, SURGICAL INSTRUMENT, DISPOSABLE FIRST AID KIT WITHOUT DRUG Stockings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-06-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-12-22
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2022-08-03
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2024-12-16
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2021-11-24
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2024-07-17
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2009-03-20
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2023-07-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2022-09-19
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-09-19
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-25
FNP	Urinal	General Hospital	Class 1	880.6730	2023-03-03
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-06-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-03-20
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2025-12-18
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2023-05-11
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-11-24
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2021-11-24
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-09-19
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2026-02-25

Official Correspondent

Joanna Zhang

US Agent Details

Dale Li Business: HTT Technologies Inc. Email: emily.zhang@3hmedical.com Phone: (954) 2785450

Related Public Records

Same Entity

NANJING 3H MEDICAL PRODUCTS 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

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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3009192857	Neodyne Biosciences, Inc.	Fremont, CA, US
3005857283	PRECO, LLC	Somerset, WI, US
3019769561	ScarPro NV	Aalter Flanders, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007607706. Last updated year: 2026. Please use registration number 3007607706 when referencing this establishment in official correspondence.