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Data / Medical devices / China / Zhejiang Medicines & Health Products I/ E Co., Ltd.

Zhejiang Medicines & Health Products I/ E Co., Ltd.: FDA-registered device maker in Hangzhou, Zhejiang, China, 11 510(k) clearances

Zhejiang Medicines & Health Products I/ E Co., Ltd. is registered with the FDA (registration 9680222) in Hangzhou, Zhejiang, China. It lists 41 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 30, 2023. 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.

Get makers like this oneWatch Zhejiang Medicines & Health Products I/ E Co., Ltd.
FDA registration number
9680222
FEI number
3003154916
Address
6-7F,310 North Zhongshan RD., Hangzhou, Zhejiang, China, 310003
Owner or operator
ZHEJIANG MEDICINES & HEALTH PRODUCTS IMPORT & EXPO (9007317)
Roles
Exporter to the US
First device listed
January 13, 1999
Registered through
2026
Brand names listed
40gsm SMS Surgical gown standard, 45-50g SMMS Surgical gown, ADHESIVE PATCH, Absorbent Cotton Wool, Adhesive Island Dressing, Adhesive bandage, Administration set, BINASAL CANNULA and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Blade, ScalpelGES1Exporter to the USaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Component, CastLGF1Exporter to the USaccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Curette, UterineHCY1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter 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, Isolation, SurgicalFYC2Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the USaccessdata.fda.gov
Mask, OxygenBYG1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter 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
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Pad, Heating, PoweredIRT2Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Stylet, Tracheal TubeBSR1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, ManualKST1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter 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
November 30, 2023K230061Insulin SyringeFMFSubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
November 4, 2022K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMISubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
August 12, 2022K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))FYCSubstantially EquivalentAllmed Medical (Hubei) Protective Products Co., Ltd.accessdata.fda.gov
August 10, 2022K220900Safety Blood Collection Needles with/without Needle HolderJKASubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
March 10, 2021K202411Surgical MaskFXXSubstantially EquivalentAllmed Medical Products Co., Ltd.accessdata.fda.gov
April 30, 2020K19229050g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical GownFYASubstantially EquivalentXuchang Zhengde Environstar Medical Products Co., Ltd.accessdata.fda.gov
January 5, 2018K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesBSPSubstantially EquivalentZhejiang Kindly Medical Devices Co., Ltd.accessdata.fda.gov
December 14, 2011K112057KDL SYRINGES AND NEEDLEFMFSubstantially EquivalentShanghai Kindly Enterprise Dev. Group Co.,accessdata.fda.gov
June 11, 2009K083687BAIXIN INTRAVASCULAR ADMINISTRATION SETFPASubstantially EquivalentAnhui Kangda Medical Products Co., Ltd.accessdata.fda.gov
February 25, 1997K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 11, 1995K951528AMSINO DISPOSABLE VIGINAL SPECULUMHIBSubstantially EquivalentAmsino Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated November 30, 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.