Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013671177

FEI Number

3013671177

Entity Name

GUANGZHOU KAIHENG K&S CO.,LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Kaiheng Technology Garden,, No.148 ChangAn Guangshan Highway, Guangzhou Guangdong 510520, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Guangzhou Kaiheng K&S Co.,Ltd. (Owner Number: 10055122)

Owner / Operator Contact Address

Kaiheng Technology Garden,, No.148 ChangAn Guangshan Highway, Guangzhou, CN-GD 510520, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NovaLine SP-C35 Transducer Protector (956007) LUOFUCON Medical Hydrogel Dressing SUNTOUCH Hemostatic Rhinobyon LUOFUCON Gelling Fiber Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2024-11-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2021-03-31
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-08-23
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2017-07-03
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2021-03-31
EFN	Cotton, Roll	Dental	Class 1	872.6050	2017-06-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-11-12
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2022-12-06
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2021-03-30
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2021-03-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-11-12

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Guangzhou Kaiheng K&S 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
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02

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

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3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
3015335038	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013671177. Last updated year: 2026. Please use registration number 3013671177 when referencing this establishment in official correspondence.