Data / Medical devices / China / Exact Medical Manufacturing, Inc.
Exact Medical Manufacturing, Inc.: FDA-registered device maker in Changzhou Jiangsu, China, 10 510(k) clearances
Exact Medical Manufacturing, Inc. is registered with the FDA (registration 3013443304) in Changzhou Jiangsu, China. It lists 17 device types. The FDA files 10 510(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
- 3013443304
- Address
- 21# Qingjiang Road, Changzhou Jiangsu, China, 213022
- 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 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Autofluorescence Imaging Adjunct Tool For Wounds | QJF | 2 | Contract manufacturer | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Complaint file establishment, Contract manufacturer, Exporter to the US, 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, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Contract 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, Exporter to the US | 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 |
| July 31, 2018 | DEN180008 | MolecuLight i:X | QCR | Unknown | MolecuLight, Inc. | accessdata.fda.gov |
| February 14, 2013 | K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| June 12, 2012 | K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| August 26, 2011 | K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| October 4, 2010 | K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | KKX | 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 |
| September 20, 2010 | K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Drape, Surgical, Antimicrobial
- All makers of Autofluorescence Imaging Adjunct Tool For Wounds
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Gown, Surgical
- All makers of Transducer, Ultrasonic, Diagnostic
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.