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Data / Medical devices / Hong Kong / Hebei Mita Biotechnology Limited

Hebei Mita Biotechnology Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance

Hebei Mita Biotechnology Limited is registered with the FDA (registration 3043011436) in Hong Kong, Hong Kong. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hebei Mita Biotechnology Limited
FDA registration number
3043011436
Address
Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui, Hong Kong, Hong Kong, 999077
Owner or operator
HEBEI MITA BIOTECHNOLOGY LIMITED (10094693)
Roles
Contract manufacturer, Manufacturer
First device listed
December 16, 2025
Registered through
2026
Brand names listed
Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,, BZY006,BZY007,BZY008,BZY009,BZY010,BZY011,BZY012,BZY013,BZY014,BZY015,BZY016,BZY017,, BZY018,BZY019,BZY020,BZY021,BZY022,BZY023,BZY024,BZY025,BZY026,BZY027,BZY028,BZY029,, BZY030,BZY031,BZY032,BZY033,BZY034, Body analyzer machine:C27,OM33,PFFX006,PFFX009,PFFX016, CLS0017,CLS0018,CLS0019,CLS0021,CLS30,CLS31,CLS32,CLS0033,CLS0037,CLS0038, CO2, Colon hydrotherapy machine:YL001,YL002,YL003,YL004,YL005,YL006,YL007 and more

Devices it lists

DeviceProduct codeClassRoleSource
Acetylcholine Chloride, Specific Reagent For Pseudo CholinesteraseDLI1Manufactureraccessdata.fda.gov
Colonic Irrigation SystemKPL2Manufactureraccessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersPZL2Manufactureraccessdata.fda.gov
Gas, Laser GeneratingNXF1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufactureraccessdata.fda.gov
Laser, Comb, HairOAP2Manufactureraccessdata.fda.gov
Marker, SkinFZZ1Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Contract manufacturer, Manufactureraccessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal EffectONF2Manufactureraccessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of CelluliteOUP2Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Contract manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov
Unit, Heating, PoweredIRQ1Manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Manufactureraccessdata.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
September 25, 2024K241860Diode Laser Hair Removal SystemGEXSubstantially EquivalentBeijing Winkonlaser Technology Limitedaccessdata.fda.gov

Compare with other makers

Updated September 25, 2024. 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.