FDA Registration Active 🇨🇳 China

LAKONG MEDICAL DEVICES CO., LTD.

Reg #: 3008559238 · FEI: 3008559238 · Expires 2026
Products
39
Proprietary Names
40
Establishment Types
5
Classifications
39

Registration Details

Registration Name
LAKONG MEDICAL DEVICES CO., LTD.
Registration Number
3008559238
FEI Number
3008559238
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No. 13 Jingci Road, Shilong
City
Dongguan Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K103498

Owner / Operator

Firm Name
Lakong Medical Devices Co., Ltd.
Operator Number
10033552
Address
NO. 13 JINGCI ROAD, SHILONG TOWN
City
DONGGUAN
State
Guangdong
Postal Code
523326
Country
CN
Correspondent
Nancy Lai

US Agent

Business Name
TPC Advanced Technology, Inc.
Contact Name
Van Wang
Address
851 S. Lawson Street
City
City Industry
State
CA
ZIP
91748
Country
US
Phone
626 8104337

Products

Device Name Product Code
Illuminator, Radiographic-Film IXC
Indicator, Physical/Chemical Sterilization Process JOJ
Wrap, Sterilization FRG
Syringe, Restorative And Impression Material EID
Accessory, Surgical Apparel LYU
Camera, Surgical And Accessories KQM
Holder, Film, X-Ray EGZ
Compressor, Air, Portable BTI
Evacuator, Oral Cavity EHZ
Applicator, Absorbent Tipped, Sterile KXG
Scaler, Periodontic EMN
Scaler, Ultrasonic ELC
Gauze / Sponge,Nonresorbable For External Use NAB
Chair, Dental, Without Operative Unit NRU
Unit, Suction Operatory EBR
Stool, Operating-Room FZM
Tray, Fluoride, Disposable KMT
Instrument, Hand, Calculus Removal ELA
Cotton, Roll EFN
Cleaner, Denture, Mechanical JER
Chair, Surgical, Non-Electrical FZK
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
Amalgamator, Dental, Ac-Powered EFD
Unit, Syringe, Air And/Or Water ECB
Tray, Surgical, Instrument FSM
Unit, Operative Dental EIA
Light, Operating, Dental EAZ
Continuous Measurement Thermometer FLL
Unit, Operative Dental, Accessories NRD
Applicator, Absorbent Tipped, Non-Sterile KXF
Agent, Polishing, Abrasive, Oral Cavity EJR
Non-Surgical Gown OEA
Cabinet, Table And Tray, Anesthesia BRY
Drill, Dental, Intraoral DZA
Cup, Prophylaxis EHK
Light, Fiber Optic, Dental EAY
Respirator, Surgical MSH
Cleaner, Ultrasonic, Medical Instrument FLG

Proprietary Names

X-ray Viewer Autoclave Indicator Tape Impression Syring/Material FACE SHIELD AdvanceCam Intra oral Camera & accessories X-ray film mounting, holder, positioner Dental air compressor Mobile-Vac SteriFlock Sterile Collection Swabs Perio Scaler, dental Ultrasonic Scaler Dental Gauze/sponge, non-sterile DENTAL CHAIR Vacuum unit Stool, Portable Stool Fluoride Tray, Disposable Hand instruments Dental cotton roll, saliva absorbent Ultrasonic Cleaner - denture PC Family Portable Dental System EYE SHIELD Face Mask D650N Digital Amalgamator Air Water Syringes, Syringe Tips - Metal & Disposable Utility tray, Surgical tips, Articulator advanceCAM TPC Operatory Light Digital Thermometer H6000 Handpiece Cleaning and Lubrication System Lubricant Non Sterile Micro Applicators Polishing powder ISOLATION GOWN Mobile delivery cabinet Handpiece, Metal Quick Disconnect disposable rubber cup Prophylaxis, cups, brushes and angles Fiber optic/Dental delivery unit N95 FACE MASK Ultrasonic cleaner

Establishment Types

Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Remanufacture Medical Device Repack or Relabel Medical Device