Skip to the page
Get started – free

Data / Medical devices / China / Suzhou Acmed Import & Export Co., Ltd.

Suzhou Acmed Import & Export Co., Ltd.: FDA-registered device maker in SUZHOU Jiangsu, China, 3 510(k) clearances

Suzhou Acmed Import & Export Co., Ltd. is registered with the FDA (registration 3006538822) in SUZHOU Jiangsu, China. It lists 27 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 9, 2009. 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.

Get makers like this oneWatch Suzhou Acmed Import & Export Co., Ltd.
FDA registration number
3006538822
Address
436 Changjiang Road 2-10016, SUZHOU Jiangsu, China, 215011
Owner or operator
SUZHOU ACMED IMPORT & EXPORT CO., LTD. (10025772)
Roles
Exporter to the US
First device listed
May 7, 2008
Registered through
2027
Brand names listed
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE, APPLICATOR, ABSORBENT TIPPED, NON-STERILE, BANDAGE; ELASTIC; PREM-WEAVE; ULTRA-WEAVE; COMPRESS BANDAGE; COMPRESS GAUZE BANDAGE, KRINKLE GAUZE ROLL, BASIN, EMESIS, BEDDING, DISPOSABLE, MEDICAL, BORDER GAUZE SPONGES; COTTON; NON-WOVEN, BULB; EAR SYRINGE; IRRIGATION, CATHETER, CONTINUOUS IRRIGATION and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Basin, EmesisFNY1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Catheter, Continuous IrrigationGBQ1Exporter to the USaccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Exporter to the USaccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Exporter to the USaccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Exporter to the USaccessdata.fda.gov
Scissors, UmbilicalHDJ1Exporter to the USaccessdata.fda.gov
Sling, ArmILI1Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Exporter to the USaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter 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
January 9, 2009K082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)KNTSubstantially EquivalentDynarex Corporationaccessdata.fda.gov
September 24, 2007K070432GENERAL SURGERY DRAPESKKXSubstantially EquivalentWelmed, Inc.accessdata.fda.gov
May 24, 2007K070431WELMED, INC. SURGICAL GOWNSFYASubstantially EquivalentWelmed, Inc.accessdata.fda.gov

Compare with other makers

Updated January 9, 2009. 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.