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Data / Medical devices / China / Suzhou Meccan Import and Export Corp.

Suzhou Meccan Import and Export Corp.: FDA-registered device maker in Suzhou Jiangsu, China, 4 510(k) clearances

Suzhou Meccan Import and Export Corp. is registered with the FDA (registration 3001650535) in Suzhou Jiangsu, China. It lists 71 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 15, 2013. Registered through 2027. 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
3001650535
Address
53 Ruyuan Rd, Suzhou Jiangsu, China, 215131
Owner or operator
SUZHOU MECCAN IMP. & EXP. CORPORATION (9045121)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
March 15, 2001
Registered through
2027
Brand names listed
3-Ply Disposable Face Mask, ANESTHESIA CIRCUIT, ARMBOARD, BANDAGES, BULKEE II GAUZE SPONGES, Bariatric Tape Measure, Blade Disarmer, COLD PACK and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Adaptor, DressingILD1Manufactureraccessdata.fda.gov
Aid, TransferIKX1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Bag, Bile CollectingEXF2Exporter to the USaccessdata.fda.gov
Bag, IceKYR1Manufacturer, Specification developeraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Board, Arm (With Cover), SterileBTX1Manufactureraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Manufacturer, Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Cane, Safety WalkKHY1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Exporter to the USaccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufacturer, Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Contract manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Contract manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-SterileNNX1Manufacturer, Specification developeraccessdata.fda.gov
Device, Incontinence, Urosheath Type, SterileEXJ1Manufacturer, Specification developeraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Manufactureraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Manufactureraccessdata.fda.gov
Endoscopic Bite BlockMNK1Exporter to the USaccessdata.fda.gov
Exerciser, Non-MeasuringION1Contract manufacturer, Manufactureraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Manufactureraccessdata.fda.gov
Finger CotLZB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure CompensatedCAX1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufacturer, Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Contract manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Contract manufactureraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufacturer, Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufacturer, Specification developeraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Contract manufactureraccessdata.fda.gov
Marker, SkinFZZ1Manufactureraccessdata.fda.gov
Monitor, Bed PatientKMI1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Contract manufacturer, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Manufactureraccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Pad, EyeHMP1Manufactureraccessdata.fda.gov
Pill Crusher/CutterOHY1Manufactureraccessdata.fda.gov
Protector, DentalBRW1Contract manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Exporter to the USaccessdata.fda.gov
Scalpel, One-PieceGDX1Contract manufactureraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Contract manufacturer, Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Spectacle, MagnifyingHOI1Contract manufactureraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Manufacturer, Specification developeraccessdata.fda.gov
Stimulator, Nerve, Battery-PoweredBXN2Contract manufactureraccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Contract manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Exporter to the USaccessdata.fda.gov
Strip, Temperature, Forehead, Liquid CrystalKPD2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, DisposableGAJ1Contract manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Contract manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Contract manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufacturer, Specification developeraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Specification developeraccessdata.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
October 15, 2013K130231NON-CONTACT INFRARED THERMOMETERFLLSubstantially EquivalentJinxinbao Electronic Co.,Ltdaccessdata.fda.gov
December 2, 2010K101577MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIESDQASubstantially EquivalentBeijing Choice Electronic Technololgy Co., Ltd.accessdata.fda.gov
January 30, 1998K980005MANAN D BAGEXFSubstantially EquivalentMedical Device Technologies, Inc.accessdata.fda.gov
January 15, 1991K904994CLOSED SYSTEM FLUSH SETDXTSubstantially EquivalentArgon Medical Corp.accessdata.fda.gov

Compare with other makers

Updated October 15, 2013. 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.