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Data / Medical devices / China / Unisource Shanghai Ltd.

Unisource Shanghai Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance

Unisource Shanghai Ltd. is registered with the FDA (registration 3007165189) in Shanghai, China. It lists 23 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 2007. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3007165189
Address
Bldg.#2, ROOM 802 Huayi Building No.2020 Zhongshan Road West, Shanghai 200235 China, Shanghai, China, 200235
Owner or operator
Unisource Shanghai Ltd. (10027023)
Roles
Exporter to the US, Repackager or relabeler, Reprocessor
First device listed
September 17, 2008
Registered through
2027
Brand names listed
Accessory, Surgical Apparel - Non-woven Face Masks, Aligner Chewies, Aligner Hook / Remover, Angle-Ease Ejector, Bouffant Caps, Mop Caps, Doctor Caps,, Comfort Soft Large, Comfort Soft Small, DENTAL MIRROR, DENTAL MOUTH MIRROR and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Container, SharpsMMK2Exporter to the US, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The CounterNKJ1Exporter to the USaccessdata.fda.gov
Evacuator, Oral CavityEHZ1Exporter to the USaccessdata.fda.gov
Floss, DentalJES1Exporter to the USaccessdata.fda.gov
Light, Surgical HeadlightEBA1Exporter to the USaccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the USaccessdata.fda.gov
Mirror, MouthEAX1Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the USaccessdata.fda.gov
Scraper, TongueLCN1Exporter to the USaccessdata.fda.gov
Shield, Protective, PersonnelKPY1Exporter to the USaccessdata.fda.gov
Strip, Polishing AgentEHM1Exporter to the USaccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the USaccessdata.fda.gov
Toothbrush, PoweredJEQ1Exporter to the USaccessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-SterileNOB1Exporter to the USaccessdata.fda.gov
Wax, Dental, IntraoralEGD1Exporter 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 25, 2007K063666SHARPS CONTAINER, MODEL 039-413MMKSubstantially EquivalentBiodex Medical Systems, Inc.accessdata.fda.gov

Compare with other makers

Updated January 25, 2007. 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.