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Data / Medical devices / Hong Kong / 3H Apotheke Limited

3H Apotheke Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance

3H Apotheke Limited is registered with the FDA (registration 3016068274) in Hong Kong, Hong Kong. It lists 20 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2006. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch 3H Apotheke Limited
FDA registration number
3016068274
Address
Unit 1132, 11/F, Liven House, 61-63 King Yip Street, Kwun Tong, Kowloon, Hong Kong, Hong Kong, 999077
Owner or operator
3H Apotheke Limited (10062037)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
December 12, 2019
Registered through
2026
Brand names listed
Dressing, Compression, Elastic Bandage, FIRST AID KIT WITHOUT DRUG, KIT, SURGICAL INSTRUMENT, DISPOSABLE

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, HygieneILS1Exporter to the USaccessdata.fda.gov
Adult Portable Bed Rails For Medical PurposesQTC1Exporter to the USaccessdata.fda.gov
Aid, TransferIKX1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Exporter to the USaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the USaccessdata.fda.gov
Detectors And Removers, Lice, (Including Combs)LJL1Exporter to the USaccessdata.fda.gov
Dispenser, Solid MedicationNXB1Exporter to the USaccessdata.fda.gov
Dressing, CompressionMHW1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Exporter to the USaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Exporter to the USaccessdata.fda.gov
UrinalFNP1Exporter to the USaccessdata.fda.gov
Utensil, EatingILC1Exporter to the USaccessdata.fda.gov
Vehicle, Motorized 3-WheeledINI2Exporter to the USaccessdata.fda.gov
Walker, MechanicalITJ1Exporter 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
December 19, 2006K062645RUIKE, MODEL 3431INISubstantially EquivalentShanghai Ruike Sports Goods Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated December 19, 2006. 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.