Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043396

FEI Number

3005461046

Entity Name

SHENZHEN JPY ION-TECH. CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 1, Building 1, Jinpengyuan Industrial Park, No. 951, Baihuayuan Road, Baihua Community, Guangming Street, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

SHENZHEN JPY ION-TECH. CO., LTD. (Owner Number: 10095160)

Owner / Operator Contact Address

Floor 1, Building 1, Jinpengyuan Industrial Park, No. 951, Baihuayuan Road, Baihua Community, Guangming Street, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal Dressing LUOFUCON PHMB Alginate Dressing (Prescription) LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC) Pasteur Pipette CALCIUM ALGINATE Ag Biatain Fiber Ag LUOFUCON Collagen Wound Dressing Standard Trocar LUOFUCON Silver Collagen Dressing VARIOUS INJECTION & SUTURING NEEDLE CUTTERS,DISSECTORS,BLOOD LANCETS Exu-Dry Burn Sheets, Conformant SUNTOUCH Topical Hemostatic Dressing foam dressing LUOFUCON HyperSorb Hydrofiber Wound Pad LUOFUCON Alginate Dressing LOOP/SQUARE ELECTRODE Disposable Bi-polar Cable Suction Coagulator LLETZ LOOP Electrode AMD antimicrobial foam dressing SUNTOUCH Eye Spear SUNTOUCH Dental Dressing Pasteur Pipette 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP) SUNTOUCH Ear Tampon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2026-05-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-22
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2026-05-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-21
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-05-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-05-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-21
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-05-21
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-05-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-05-21
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2026-05-08
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2026-05-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-05-09
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2026-05-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-21
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2026-05-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-08
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2026-05-22
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2026-05-21
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2026-05-21
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2026-05-21
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2026-05-21

Official Correspondent

Liang He

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

SHENZHEN JPY ION-TECH. 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043396. Last updated year: 2026. Please use registration number 8043396 when referencing this establishment in official correspondence.