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Data / Medical devices / China / Dongguan Wanjin Industrial Co., Ltd

Dongguan Wanjin Industrial Co., Ltd: FDA-registered device maker in DongGuang Guangdong, China, 1 510(k) clearance

Dongguan Wanjin Industrial Co., Ltd is registered with the FDA (registration 3010656982) in DongGuang Guangdong, China. It lists 41 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 14, 2019. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3010656982
Address
SongBoTang Area, ChangPing, DongGuang Guangdong, China, 523561
Owner or operator
Dongguan Wanjin Industrial Co., Ltd (10045813)
Roles
Manufacturer, Remanufacturer, Repackager or relabeler
First device listed
December 31, 2013
Registered through
2026
Brand names listed
Air Water Syringe, B&B Cleaning Oil, Bracket, Burs, CUP, Cotton Roll, Cover Gowns, Dental Light and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Repackager or relabeleraccessdata.fda.gov
Aligner, Beam, X-RayEHA1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Remanufactureraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Remanufactureraccessdata.fda.gov
Catheter, Continuous IrrigationGBQ1Repackager or relabeleraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dental Barriers And SleevesPEM2Manufactureraccessdata.fda.gov
Denture, Plastic, TeethELM2Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
Gown, ExaminationFME1Repackager or relabeleraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeleraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Holder, Radiographic Cassette, Wall-MountedIXY1Remanufactureraccessdata.fda.gov
Light, Fiber Optic, DentalEAY1Repackager or relabeleraccessdata.fda.gov
Light, Operating, DentalEAZ1Remanufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Repackager or relabeleraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Repackager or relabeleraccessdata.fda.gov
Motor, Surgical Instrument, Pneumatic PoweredGET1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Oil, ClearingIJZ1Repackager or relabeleraccessdata.fda.gov
Pouch, ColostomyEZQ1Repackager or relabeleraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Remanufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, ExemptPTX2Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
Tip, Rubber, Oral HygieneJEW1Repackager or relabeleraccessdata.fda.gov
Tube Impression And MatrixKCQ1Repackager or relabeleraccessdata.fda.gov
Tube Mount, X-Ray, DiagnosticIYB1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 14, 2019K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopePEMSubstantially EquivalentUnipack Medical Corporationaccessdata.fda.gov

Compare with other makers

Updated June 14, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.