Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017896194

FEI Number

3017896194

Entity Name

Dongguan King Medical Technology Co.,Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 102, Building 2, Meilin Industrial Park, No.71, Tangxiaduan, Dongshen Road, Tangxia Town, Dongguan Guangdong 523000, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Shenzhen king medical packaging sterilization service Co.ltd (Owner Number: 10053058)

Owner / Operator Contact Address

901 A-2, Building 5, Hongchuang Science and Technology Center, Xikeng Community, Fucheng Street, Longhua District, shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VitaVitro Double Lumen Oocyte Retrieval Needle, model ORND-17G VitaVitro Single Lumen Oocyte Retrieval Needle, model ORNS-17G, ORNS-18G Radux Steradian Shield Auryon Atherecomy System(Catheters) Sterilized I Pak -Mirror Auryon Atherectomy Catheters Auryon Atherectomy Catheter 1.5 Mm Xl (Exm -4010-0000) Auryon Atherectomy Catheter 0.9 Mm Xl, Hydrophilic Coating (Exm-4011-H000) Auryon Atherectomy Catheter 1.5 Mm Xl, Hydrophilic Coating (Exm-4010-H000) Auryon Atherectomy Catheter 0.9 Mm Xl (Exm-4011-0000) Radux Steradian Shield TRAY, SURGICAL Sterilized I Pak -Probe PROBE, PERIODONTIC SYSTEM, DELIVERY, ALLERGEN AND VACCINE Medtronic, Rotatable connector, model 5944RL VitaVitro Straw Set, model ZG-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2025-06-15
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-11-18
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-09-18
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-12-22
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-06-25
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-03-14
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-11-18
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-11-21
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2016-12-22
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2020-05-05
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-02-14
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2025-06-15
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2025-06-15

Official Correspondent

ALISE LIU

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

Shenzhen king medical packaging sterilization service 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
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K000299	Biomedex, Inc.	DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D	2000-04-28
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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3008876063	KITAZATO CORPORATION	Fuji Shizuoka, JP
3005987240	ALLWIN MEDICAL DEVICES, INC.	ANAHEIM, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017896194. Last updated year: 2026. Please use registration number 3017896194 when referencing this establishment in official correspondence.