Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013462478

FEI Number

3013462478

Entity Name

SUZHOU LEAPMED HEALTHCARE CORPORATION

City/State/Country

suzhou Jiangsu, CN

Establishment Address

Building 7, No. 188 Fuchunjiang Road, SND, suzhou Jiangsu 215163, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Suzhou Leapmed Healthcare Corporation (Owner Number: 10061699)

Owner / Operator Contact Address

Building 7, No. 188 Fuchunjiang Road, SND, Suzhou, CN-JS 215163, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011265

PMA Number

N/A

All Registered Proprietary Names

Disposable Coaxial Biopsy Needle GG514 GG515 GG516 GG517 GG518 GG519 GG520 GG521 GG522 GG523 GG524 GG525 GG526 GG540 GG541 GG542 GG543 GG546 GG547 GG548 GG549 GG550 GG551 GG552 GG553 GG554 10208203 10207803 10207803 10207103 10207103 10207903 10207903 10208803 10208803 10200603 10204103 10204103 10203603 10203603 10203403 10203403 10211803 10211803 10203703 10207603 10207603 10207503 10207503 10201303 10201303 10205903 10205903 GG205 GG206 GG207 GG208 GG209 GG210 GG211 GG212 GG213 GG214 GG215 GG216 GG217 10204703 10204903 10204903 10206903 10206903 10205003 10205003 10203503 10203503 10202103 10202103 10205703 10205703 10212003 10212003 10207003 10207003 10202203 10202203 10202103 10202103 10204803 10204803 10207003 10207003 10212203 EG139 EG140 EG141 EG144 EG145 EG146 EG147 EG148 EG149 EG150 EG151 EG152 EG153 EG154 GG218 GG219 GG220 GG221 GG222 GG223 GG224 GG225 GG226 GG227 GG228 GG229 GG500 10208503 10201403 10201403 10206003 10206003 10206303 10206303 10205503 10205503 GG006 GG007 GG008 GG009 GG010 GG011 GG012 GG013 GG014 GG015 GG016 GG017 GG018 10203103 10203103 10202103 10202103 10208103 10208103 10204603 10204603 10204703 EG155 EG156 EG157 EG158 EG159 EG160 EG161 EG174 EG175 EG176 EG177 EG178 EG179 EG188 GG701 GG702 GG703 GG704 GG705 GG706 GG707 GG708 GG709 GG710 GG711 GG712 GG713 10214303 10214303 10214403 10214403 10214503 10214503 10213703 10213703 10213803 10208003 10213903 10213903 10214003 10214003 10214103 10214103 10214203 10214203 10206903 10205003 10205003 10203503 10203503 10202203 10202203 10204803 10204803 10204703 10204703 10204603 10204603 10204203 10204203 10204903 10204903 10206903 GG501 GG502 GG503 GG504 GG505 GG506 GG507 GG508 GG509 GG510 GG511 GG512 GG513 EG189 EG190 EG191 EG196 EG197 EG198 EG199 EG202 EG203 EG204 EG205 EG508 EG509 EG510 10204403 10206403 10206403 10202403 10202403 10202503 10202503 10205603 10205603 10212803 10212803 10212803 10212803 10203903 10203903 10204203 10204203 10201803 10203003 10203003 10202803 10202803 10200703 10200703 10200203 10200203 10202303 10201803 10201003 10201003 10202503 10202503 10204503 10204503 10211503 10211503 10210003 10210003 10212103 10212103 10202903 10202903 10208503 10208503 10208003 GG019 GG020 GG021 GG022 GG023 GG024 GG025 GG026 GG027 GG028 GG029 GG100 GG101 10204503 10204503 10201903 10201903 10202003 10202003 10206803 10206803 10200603 GG115 GG116 GG117 GG118 GG119 GG120 GG122 GG123 GG200 GG201 GG202 GG203 GG204 10205103 10205103 10201503 10201503 10201603 10201603 10210203 10210203 10200303 10207203 10207203 10207203 10207203 10209703 10209703 10202603 10202603 10203703 GG714 GG715 GG716 GG717 GG718 GG719 GG720 GG721 GG722 GG723 GG724 GG725 EG123 EG124 EG125 EG126 EG127 EG128 EG129 EG130 EG131 EG134 EG135 EG136 EG137 EG138 10204003 10204003 10200103 10200103 10206603 10206603 10209803 10209803 10208503 10212203 10212303 10212303 10212103 10212103 10200803 10200803 10203903 10203903 10200303 10206203 10206203 10207403 10207403 10206103 10206103 10202703 10202703 10203803 10203803 10202103 10202103 10204203 10204203 10204303 10204303 10201103 GG102 GG103 GG104 GG105 GG106 GG107 GG108 GG109 GG110 GG111 GG112 GG113 GG114 GG527 GG528 GG529 GG530 GG531 GG532 GG533 GG534 GG535 GG536 GG537 GG538 GG539 Leapmed revised Order Code:10400903 10401003 10208703 10208703 10208603 10208603 10201103 10201803 10201803 10200403 10200403 10201203 10201203 10205303 10205303 10202003 10202003 10203003 10203003 10202803 10202803 10202303 10203303 10203303 ULTRASOUND TRANSDUCER COVER-AMD Order Code: EG004 EG003 EG002 EG006 EG001 EG005 EG112 EG113 EG114 EG115 GG730 GG731 10200503 10200503 10205803 10205803 10200903 10200903 10201703 10201703 10208203 10213803 10213103 10213103 10213103 10213103 10203503 10203503 10203503 10203503 EG511 EG512 EG513 EG514 EG515 EG520 EG521 GG000 GG001 GG002 GG003 GG004 GG005 10202303 10203303 10203303 10212503 10212503 10203203 10203203 10203103 10203103 GG555 GG556 GG557 GG558 GG559 GG560 GG561 GG562 GG563 GG566 GG567 GG568 GG569 GG570 GG571 GG572 GG573 GG576 GG577 GG578 GG579 GG580 GG581 GG582 GG583 GG700 EG100 EG101 EG104 EG105 EG106 EG107 EG110 EG111 EG118 EG119 EG120 EG121 EG122 10211903 10211903 10201003 10201003 10205203 10205203 10206503 10206503 10204403

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2022-07-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-11-11

Official Correspondent

Leah Wang

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Suzhou Leapmed Healthcare Corporation

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
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013462478. Last updated year: 2026. Please use registration number 3013462478 when referencing this establishment in official correspondence.