HEBEI MITA BIOTECHNOLOGY LIMITED

FDA Device Registration & Listing · Hong Kong, HK · Registration 3043011436

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043011436
FEI Number
3043011436
Entity Name
HEBEI MITA BIOTECHNOLOGY LIMITED
City/State/Country
Hong Kong, HK
Establishment Address
Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui,, Hong Kong 999077, HK
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HEBEI MITA BIOTECHNOLOGY LIMITED (Owner Number: 10094693)
Owner / Operator Contact Address
Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui,, Hong Kong, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OMG199,OMG198,OMG211,OMG217,OMG219,HF001,HF002,HF003,HF004,HF005,OMG193,HF006,HF0022,HF0017,HF0021,HF0026,HF007, High Intensity Focused Ultrasound System:OM18,OM32 ,OMD04,OMF71,OME72,OM121,OM120,OM140,OMG77,OMG79,OMG108,OMG114, HF0038,HF0039,HF0040,HF0041,HF0042,HF0043 HF0024,HF0025,AGF65,HF0028,HF0029,HF0031,HF0032,HF0033,HF0034,HF0035,HF0036,HF0037, HF008,HF0023,HF009,HF0010,HF0011,HF0012,HF0013,HF0014,OMG135,HF0016,HF0018,HF0019,HF0020, OMG131,OMG165,OMG210,OMG166,OMG167,OMG177,OMG191,OMG206,HF0030,OMG207, PM029, PM033, PM034, PM035, PM036, PM037, PM038, JXY-PM001, JXY-PM0012, XOM-PM001, XOM-PM002 Picosecond Laser Machine:OMG30, OMG172, PM001, PM002, PM003, PM004, PM005, PM006, PM007, PM008, PM009, PM011, PM012, PM015, PM016, PM017, PM022, PM023, PM024, PM025, PM026, PM028, Multi-functional 980 1470 Diode Laser Machine:LLY006, LLY007, LLY008 ,LLY0030,LLY0043, OM213 Shockwave therapy:AG213,AGF66,AME25,MT07,MT08,OM213,OMG87,OMG110,OMG111,OMG119,OMG157, OMG192,OMG208,OMG212,OMG221,JXY-CJB001,XOM-LLY001,XOM-LLY002,YTL-CJB001 LD22,LD263,OMG37,LD24,LD25,LD26,LD27,LD28,LD29,LD30 Multi-functional Cryolipolysis Slimming System:OMG09,OMG26,OMF72,OME57,OM253,OMF72,OMF76,OME78,OMG105,OMC86,OM173,OMD35, OMG126,OMG176,OMG184,OMG185,OMG186,OMG187,OMG188,LD015,OMG200,OMG202, OMG216,LD005,LD006,LD007,LD009,LD010,LD11,LD12,LD013,LD014,LD016,LD017,LD018,LD19,LD20, OMG17,OMG36,OMG45,OMG47,OMG74,OMG80,OMG83,OMG109,OMG112,OMG113,OMG90, DZ019, DZ010, DZ021, DZ027, DZ030, DZ031, DZ032, DZ033, DZ034, DZ035, DZ036, DZ037 Fractional CO2 Laser System Machine:AGF80, AME85, DZ001, DZ008, DZ009, DZ010, DZ012, DZ013, DZ014, DZ015, DZ016, DZ018, Colon hydrotherapy machine:YL001,YL002,YL003,YL004,YL005,YL006,YL007 CLS0017,CLS0018,CLS0019,CLS0021,CLS30,CLS31,CLS32,CLS0033,CLS0037,CLS0038 Muscle Stimulation EMS Sculpting Machines:AME83,KSH64,OMG127,OMG128,OMG129,OMG174, OMG150,OMG-PST001,D03,OMD76,OM167,OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149, CO2 ELECTRONIC MUSCLE STIMULATOR JXY-TMY002, JXY-TMY003, JXY-TMY004, JXY-TMY005, XOM-TMY001, XOM-TMY002, XOM-TMY003 Diode Laser Hair Removal System:AG108, AME50, OM101, OMG32, OMG121, OMG132, OMG134, OMG137, OMG138, OMG178, TMY036, TMY037, TMY038, TMY039, TMY040, TMY041, TMY042, TMY043, TMY044, JXY-TMY001, TMY026, TMY027, TMY028, TMY029, TMY030, TMY031, TMY032, TMY033, TMY034, TMY035, TMY011, TMY012, TMY013, TMY014, TMY015, TMY016, TMY017, TMY018, TMY019, TMY020, TMY021, TMY022, TMY023, TMY024, TMY025, OMG179, OMG181, OMG214, OMG218, TMY001, TMY002, TMY003, TMY004, TMY005, TMY006, TMY007, TMY008, TMY009, TMY010, Hair Regrowth Machine:OMG118,OMG153,SFY001,SFY002,SFY003,SFY004,YTL-SFY005 Diode Laser Hair Removal System Skin analyzer machine:KSH75,PFFX001,PFFX002,PFFX005,OM26,PFFX005,PFFX008,PFFX0011,PFFX0014 Spa capsule:AGF74,AM226,KS43,OMG125 Hyperbaric oxygen chamber:GY001,GY002,GY003,GY004,GY005,GY006 Facial Spa Oxygen Hydro Facial Beauty System:AG51,AG154,AGF04,AGF54,AGF55,AGF68,AMB53,Keysun160,ksh75,Omd85,Omg25,Omg57, Body analyzer machine:C27,OM33,PFFX006,PFFX009,PFFX016 Omg205,Omg209,Omg213,Omg215,JXY-SYY001,JXY-SYY002,JXY-SYY003,JXY-SYY004, Omg68,Omg69,Omg89,Omg99,Omg120,Omg139,Omg140,Omg142,Omg158,Omg170,Omg197,Omg203, JXY-SYY005,JXY-SYY006,JXY-SYY007, XOM-SYY001,YTL-SYY001,YTL-SYY002,YTL-SYY003 Hyperbaric Oxygen Chamber:OMG-TKC009,OMG-TCK011,JXY-GYYC001 BZY030,BZY031,BZY032,BZY033,BZY034 OMG194,OMG195,OMG196,OMG201,OMG220,BZY001,BZY002,BZY003,BZY004,BZY004,BZY005, RF Cavitation machine:AGF67,AMB97,OM63,OMG16,OMG16,OMG75,OMG85,OMG97,OMG122,OMG123,OMG124,OMG133, BZY018,BZY019,BZY020,BZY021,BZY022,BZY023,BZY024,BZY025,BZY026,BZY027,BZY028,BZY029, BZY006,BZY007,BZY008,BZY009,BZY010,BZY011,BZY012,BZY013,BZY014,BZY015,BZY016,BZY017,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-12-16
NXF Gas, Laser Generating General, Plastic Surgery Class 1 878.4810 2025-12-16
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-12-16
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2025-12-16
OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite General, Plastic Surgery Class 2 878.4790 2025-12-16
DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase Clinical Toxicology Class 1 862.3240 2025-12-16
KPL Colonic Irrigation System Gastroenterology, Urology Class 2 876.5220 2025-12-16
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2025-12-16
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2025-12-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-12-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-16
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2025-12-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-16
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2025-12-16
IRQ Unit, Heating, Powered Physical Medicine Class 1 890.5950 2025-12-16

Official Correspondent

Shujuan Zhao

US Agent Details

Yuan Dan Email: serviceHYus@outlook.com Phone: (805) 3513025

Related Public Records

Same Entity

HEBEI MITA BIOTECHNOLOGY LIMITED
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K192521 Shangdong Huamei Technology Co., Ltd. Intense Pulsed Light Treatment System 2019-12-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043011436. Last updated year: 2026. Please use registration number 3043011436 when referencing this establishment in official correspondence.
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