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Data / Medical devices / Malaysia / YCH Distripark Sdn Bhd

YCH Distripark Sdn Bhd: FDA-registered device maker in Shah Alam Selangor, Malaysia, 20 510(k) clearances

YCH Distripark Sdn Bhd is registered with the FDA (registration 3048101437) in Shah Alam Selangor, Malaysia. It lists 80 device types. The FDA files 20 510(k) clearances under its listings, the newest dated July 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch YCH Distripark Sdn Bhd
FDA registration number
3048101437
Address
Lot 22203, Jalan Kemuning 33/52, Taman Teknologi, Seksyen 33, Shah Alam Selangor, Malaysia, 40400
Owner or operator
YCH Distripark Sdn Bhd (10041986)
Roles
Exporter to the US
First device listed
September 27, 2012
Registered through
2026
Brand names listed
AESCULAP, Aesculap, Applier, BIOPSY FORCEPS, Blade, Clamp, Curette, Depressor and more

Devices it lists

DeviceProduct codeClassRoleSource
Anesthesia Conduction KitCAZ2Exporter to the USaccessdata.fda.gov
Applier, Staple, Surgical,GEF1Exporter to the USaccessdata.fda.gov
Applier, Surgical, ClipGDO1Exporter to the USaccessdata.fda.gov
Blade, ScalpelGES1Exporter to the USaccessdata.fda.gov
Burnisher, OperativeEKJ1Exporter to the USaccessdata.fda.gov
Carver, Wax, DentalEIK1Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Exporter to the USaccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Exporter to the USaccessdata.fda.gov
ClampHXD1Exporter to the USaccessdata.fda.gov
Clamp, Non-ElectricalFFN1Exporter to the USaccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Exporter to the USaccessdata.fda.gov
Clamp, UmbilicalHFW2Exporter to the USaccessdata.fda.gov
Clamp, UterineHGC1Exporter to the USaccessdata.fda.gov
Clamp, VascularDXC2Exporter to the USaccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Exporter to the USaccessdata.fda.gov
CuretteHTF1Exporter to the USaccessdata.fda.gov
Curette, Surgical, General UseFZS1Exporter to the USaccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Exporter to the USaccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Exporter to the USaccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Exporter to the USaccessdata.fda.gov
Excavator, Dental, OperativeEKC1Exporter to the USaccessdata.fda.gov
Explorer, OperativeEKB1Exporter to the USaccessdata.fda.gov
ExtractorHWB1Exporter to the USaccessdata.fda.gov
ForcepsHTD1Exporter to the USaccessdata.fda.gov
Forceps, Articulation PaperEFK1Exporter to the USaccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Exporter to the USaccessdata.fda.gov
Forceps, Dressing, DentalEFL1Exporter to the USaccessdata.fda.gov
Forceps, EntKAE1Exporter to the USaccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Exporter to the USaccessdata.fda.gov
Forceps, OphthalmicHNR1Exporter to the USaccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Exporter to the USaccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Exporter to the USaccessdata.fda.gov
Forceps, Wire HoldingHYA1Exporter to the USaccessdata.fda.gov
Guide, Needle, SurgicalGDF1Exporter to the USaccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Exporter to the USaccessdata.fda.gov
Handle, Instrument, DentalEJB1Exporter to the USaccessdata.fda.gov
Handle, ScalpelGDZ1Exporter to the USaccessdata.fda.gov
HemostatHRQ1Exporter to the USaccessdata.fda.gov
Hemostat, SurgicalEMD1Exporter to the USaccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Exporter to the USaccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Exporter to the USaccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Exporter to the USaccessdata.fda.gov
Hook, TrachealKCH1Exporter to the USaccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Exporter to the USaccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Exporter to the USaccessdata.fda.gov
Instruments, Dental HandDZN1Exporter to the USaccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Exporter to the USaccessdata.fda.gov
Introducer, CatheterDYB2Exporter to the USaccessdata.fda.gov
Knife, PeriodonticEMO1Exporter to the USaccessdata.fda.gov
Knife, SurgicalEMF1Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Mirror, MouthEAX1Exporter to the USaccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Non-Coring (Huber) NeedlePTI2Exporter to the USaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the USaccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Exporter to the USaccessdata.fda.gov
Probe, PeriodonticEIX1Exporter to the USaccessdata.fda.gov
Pump, Infusion, ElastomericMEB2Exporter to the USaccessdata.fda.gov
Punch, SurgicalLRY1Exporter to the USaccessdata.fda.gov
RaspHTR1Exporter to the USaccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Exporter to the USaccessdata.fda.gov
Remover, CrownEIS1Exporter to the USaccessdata.fda.gov
RetractorGAD1Exporter to the USaccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the USaccessdata.fda.gov
Retractor, EntKAL1Exporter to the USaccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Exporter to the USaccessdata.fda.gov
Retractor, Self-RetainingFFO1Exporter to the USaccessdata.fda.gov
Retractor, VaginalHDL1Exporter to the USaccessdata.fda.gov
Scaler, PeriodonticEMN1Exporter to the USaccessdata.fda.gov
Scalpel, One-PieceGDX1Exporter to the USaccessdata.fda.gov
Scissors, General, SurgicalLRW1Exporter to the USaccessdata.fda.gov
Scissors, OphthalmicHNF1Exporter to the USaccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Exporter to the USaccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Exporter to the USaccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Exporter to the USaccessdata.fda.gov
Twister, WireHXS1Exporter to the USaccessdata.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
July 26, 2024K241845Introcan Safety® 2 IV CatheterFOZSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
June 23, 2022K220756Introcan Safety 2 IV CatheterFOZSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
May 14, 2022K220626Introcan Safety IV CatheterFOZSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
February 11, 2022K213664B. Braun Introcan Safety 2 IV CatheterFOZSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
October 25, 2021K213085Introcan Safety 3 Closed IV CatheterFOZSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
June 11, 2018K173803Omnican fineFMISubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
November 3, 2017K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y sitePTISubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
March 2, 2016K152050PencylcapFMISubstantially EquivalentB.Braun Melsungen AGaccessdata.fda.gov
August 20, 2013K131842STERICAN CANNULAFMISubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
December 22, 2011K112515PENCAN SPINAL NEEDLEBSPSubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
July 15, 2008K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPMEBSubstantially EquivalentWestmed, Inc.accessdata.fda.gov
November 8, 2007K072247STERICAN HYPODERMIC NEEDLESFMISubstantially EquivalentB.Braun Medical, Inc.accessdata.fda.gov
January 13, 2000K992053AESCULAP VASCULAR INSTRUMENTSDXCSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
April 3, 1997K962696PERIFIX PEDIATRIC EPIDURAL KITCAZUnknownB.Braun Medical, Inc.accessdata.fda.gov
January 26, 1994K932569PENCIL POINT SPINAL NEEDLE AND TRAYBSPSubstantially EquivalentB. Braun of America, Inc.accessdata.fda.gov
December 13, 1993K932400ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAYBSPUnknownB. Braun of America, Inc.accessdata.fda.gov
January 25, 1982K820047SPINOCAN SPINAL NEEDLEBSPSubstantially EquivalentBurron Medical Products, Inc.accessdata.fda.gov
December 3, 1981K813236EPICAN EPIDURAL CANNULA, BEVEL ACCORDBSPSubstantially EquivalentBurron Medical Products, Inc.accessdata.fda.gov
December 3, 1981K813186PERFIX SET FOR EPIDURAL ANESTHESIA W/TUOCAZSubstantially EquivalentBurron Medical Products, Inc.accessdata.fda.gov
December 3, 1981K813179PERICAN, EPIDURAL CANNULABSPSubstantially EquivalentBurron Medical Products, Inc.accessdata.fda.gov

Compare with other makers

Updated July 26, 2024. 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.