EXACT MEDICAL MANUFACTURING, INC.

FDA Device Registration & Listing · Changzhou Jiangsu, CN · Registration 3013443304

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
3013443304
FEI Number
3013443304
Entity Name
EXACT MEDICAL MANUFACTURING, INC.
City/State/Country
Changzhou Jiangsu, CN
Establishment Address
21# Qingjiang Road, Changzhou Jiangsu 213022, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Exact Medical Manufacturing, Inc. (Owner Number: 10053949)
Owner / Operator Contact Address
21# Qingjiang Road, Changzhou, CN-JS 213022, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K111535
PMA Number
N/A

All Registered Proprietary Names

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV DX Dark Drape EMM SURGICAL DRAPE SMS W/PE SIDES Intraoperative Probe Cover, Transducer Cover, Probe Cover Dark Drape 34"x24" Paper Filter w/ Foam Gasket Kit, Convenience SmokeStop EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV Probe Cover Ultrasound Probe Cover Transducer Cover Ultrasound Cover Tourniquet EMM SURGICAL GOWN-SMS WITH PE LAYER EMM EQUIPMENT COVER-POLYTHYLENE DrillCover - SteriGo Sterile Drapes Autoguide 15 pack Ice Compression Bandage Ice Pack Hays Innovation Anchor Sound Device Face Shield Compression Garment Face Shield 9" long x 13" wide w/Drape- 13"x 13" FaceDrape Self Donning Tabs Face Shield, attahced with Full Covering FaceDrape, Wide Syringe, Luer Slip SurgiCount®+ Reader Cover SurgiCount®+ Sponge Counting Bag EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES DropStop Mayo Cover Film Table Cover DropStop Kit BTC (Back Table Cover) CG-SM, CG-SM-M - Ultrasound SuperProbe Cover Kit - Clear Guide Medical DL D361619 Transport Pad Scope Transport Pad Tauro Towel Hemorrhage View C-Section Drape Specialty Drape Line-Direct Anterior Hip Universal Lower Extremity Drape Universal Upper Extremity Drape EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2017-01-25
QJF Autofluorescence Imaging Adjunct Tool For Wounds General, Plastic Surgery Class 2 878.4550 2021-08-17
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2017-01-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-08-16
QCR Wound Autofluorescence Imaging Device General, Plastic Surgery Class 1 878.4165 2018-12-14
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2017-12-06
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2019-09-12
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2022-02-11
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2017-01-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-08-16
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2023-12-06
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2017-01-25
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2017-01-25
KYR Bag, Ice General Hospital Class 1 880.6050 2017-08-31
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2017-08-31
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2022-12-08
LWH Counter, Sponge, Surgical General Hospital Class 1 880.2740 2024-06-27
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2017-01-25
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2018-04-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2017-01-25

Official Correspondent

Ryan Power

US Agent Details

Ryan Power Business: Exact Medical Manufacturing, Inc. Email: FDA@exactmm.com Phone: (716) 6810076

Related Public Records

Same Entity

Exact Medical Manufacturing, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018781093 EXACT MEDICAL MANUFACTURING, INC. Changzhou Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013443304. Last updated year: 2026. Please use registration number 3013443304 when referencing this establishment in official correspondence.
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