Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009655869

FEI Number

3009655869

Entity Name

Zhejiang Longterm Medical Technology Co., LTD

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

Fuxi Street, 277 Shuangshan Road; Moganshan Jingjikaifaqu Wukangzhen Deqingxian, Huzhou Zhejiang 313299, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Longterm Medical Technology Co., LTD (Owner Number: 10040883)

Owner / Operator Contact Address

ShuangShan Road 277, Fuxi Street, National High-tech District, Deqing, CN-ZJ 313200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202823

PMA Number

N/A

All Registered Proprietary Names

Drape Protector face mask No sting barrier film spray hydrogel dressing Alginate Dressing Gelling fibre dressing Sleeve pad Scar gel Chest Pillow Freevent Dressing SoftFoam hydrocolloid foam dressing silicone foam dressing super absorbency dressing Heel foam dressing foam dressing nonwoven wound dressing hydrocolloid dressing silicone dressing transparent island dressing silicone dressing ultimate Table Cover, Sleeve pad cool patch collection bag Urinary collection bag Board, Arm (With Cover), Sterile hydrogel pad Anti-leakage strip Skin protective paste Hydrocolloid skin protective ring Protective dressing wipe Skin protective powder Hydrocolloid skin barrier LT Antibacterial Alginate with Silver Dressing compressing hemostatic dressing Bouffant Cap Innomed NPWT Silicone Foam dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2015-11-06
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-07
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2022-03-09
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2012-05-29
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-05-29
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-05-21
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2019-11-24
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-11-06
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-05-29
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2015-04-10
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2023-02-22
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2012-07-10
BTX	Board, Arm (With Cover), Sterile	General, Plastic Surgery	Class 1	878.3910	2017-06-14
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2024-01-25
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2012-07-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-09-17
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2023-11-27
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-11-06
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2021-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Zhejiang Longterm 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

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 3009655869. Last updated year: 2026. Please use registration number 3009655869 when referencing this establishment in official correspondence.