Data / Medical devices / China / Exact Medical Manufacturing, Inc.

Exact Medical Manufacturing, Inc.: FDA-registered device maker in Changzhou Jiangsu, China, 4 510(k) clearances

Name: Exact Medical Manufacturing, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Exact Medical Manufacturing, Inc. is registered with the FDA (registration 3018781093) in Changzhou Jiangsu, China. It lists 17 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 12, 2023. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3018781093
Address: No. 101 Huashan Road Xin Bei District, Changzhou Jiangsu, China, 213032
Owner or operator: Exact Medical Manufacturing, Inc. (10053949)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer
First device listed: January 25, 2017
Registered through: 2027
Brand names listed: 34"x24" Paper Filter w/ Foam Gasket, Anti-Fog Scope Warmer, BTC (Back Table Cover), CG-SM, CG-SM-M - Ultrasound SuperProbe Cover Kit - Clear Guide Medical DL D361619, Compression Garment, DX Dark Drape, Dark Drape, Disposable Arm/Femoral Drape and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Autofluorescence Imaging Adjunct Tool For Wounds	QJF	2	Contract manufacturer	accessdata.fda.gov
Bag, Ice	KYR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Manufacturer	accessdata.fda.gov
Counter, Sponge, Surgical	LWH	1	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Complaint file establishment, Reprocessor	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US, Repackager or relabeler, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Contract manufacturer	accessdata.fda.gov
Wound Autofluorescence Imaging Device	QCR	1	Contract manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 12, 2023	K222460	Intraoperative Ultrasound Probe Cover	ITX	Substantially Equivalent	Exact Medical Manufacturing	accessdata.fda.gov
August 13, 2021	K211969	EMM Ultrasonic Transducer Cover	ITX	Substantially Equivalent	Exact Medical Manufacturing	accessdata.fda.gov
August 26, 2011	K111535	EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER	FYA	Substantially Equivalent	Exact Medical Manufacturing, Inc.	accessdata.fda.gov
September 20, 2010	K101689	EMM EQUIPMENT COVER-POLYTHYLENE	KKX	Substantially Equivalent	Exact Medical Manufacturing, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 12, 2023. 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.