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Data / Medical devices / China / Dongguan Hong De Medical Plastic Products Co. Ltd.

Dongguan Hong De Medical Plastic Products Co. Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 1 510(k) clearance

Dongguan Hong De Medical Plastic Products Co. Ltd. is registered with the FDA (registration 3010305275) in Dongguan Guangdong, China. It lists 32 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2023. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Dongguan Hong De Medical Plastic Products Co. Ltd.
FDA registration number
3010305275
Address
16 / 19 Yin Song Road, Shang Yuan, Qing Xi, Dongguan Guangdong, China, 523000
Owner or operator
Dongguan Hong De Medical Plastic Products Co. (10043215)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
First device listed
January 30, 2013
Registered through
2027
Brand names listed
COVER PROBE W/GEL & BANDS, Probe Cover Kit, Specimen Container, Sterile Burn Sheet, Tracheobronchial Suction Catheter Kit, Warmer, irrigation solution

Devices it lists

DeviceProduct codeClassRoleSource
Aid, TransferIKX1Contract manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Contract manufactureraccessdata.fda.gov
Bandage, CastITG1Contract sterilizeraccessdata.fda.gov
Basin, EmesisFNY1Contract manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Collector, OstomyEXB1Manufactureraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Contract sterilizeraccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Contract manufacturer, Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufactureraccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Contract manufactureraccessdata.fda.gov
Cover, Barrier, ProtectiveMMP2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract sterilizeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract sterilizeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Contract sterilizeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract sterilizeraccessdata.fda.gov
General Purpose Instrument TrayPXV1Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gown, SurgicalFYA2Contract sterilizeraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract sterilizeraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Manufactureraccessdata.fda.gov
Sheet, BurnFPY1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Contract sterilizer, Manufactureraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Repackager or relabeleraccessdata.fda.gov
Warmer, Irrigation SolutionLHC1Contract manufactureraccessdata.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
January 11, 2023K221278Transducer Probe CoverITXSubstantially EquivalentHony Medical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 11, 2023. 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.