BEUDAMED
    FDA Registration Active 🇨🇳 China

    EXACT MEDICAL MANUFACTURING, INC.

    Reg #: 3013443304 · FEI: 3013443304 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    54
    Establishment Types
    7
    Classifications
    17

    Registration Details

    Registration Name
    EXACT MEDICAL MANUFACTURING, INC.
    Registration Number
    3013443304
    FEI Number
    3013443304
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21# Qingjiang Road
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K121919

    Owner / Operator

    Firm Name
    Exact Medical Manufacturing, Inc.
    Operator Number
    10053949
    Address
    21# Qingjiang Road
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213022
    Country
    CN
    Correspondent
    Ryan Power

    US Agent

    Business Name
    Exact Medical Manufacturing, Inc.
    Contact Name
    Ryan Power
    Address
    4917 William St Ste C
    City
    Lancaster
    State
    NY
    ZIP
    14086
    Country
    US
    Email
    [email protected]
    Phone
    716 6810076

    Products

    Device Name Product Code
    Drape, Surgical, Antimicrobial KKX
    Autofluorescence Imaging Adjunct Tool For Wounds QJF
    Transducer, Ultrasonic, Diagnostic ITX
    Wound Autofluorescence Imaging Device QCR
    Wrap, Sterilization FRG
    Kit, Surgical Instrument, Disposable KDD
    Tubing, Noninvasive GAZ
    Gown, Surgical FYA
    Tourniquet, Nonpneumatic GAX
    Bag, Ice KYR
    Accessory, Surgical Apparel LYU
    Syringe, Irrigating (Non Dental) KYZ
    Counter, Sponge, Surgical LWH
    Drape, Surgical, Exempt PUI
    Shield, Protective, Personnel KPY
    Instrument, Manual, Surgical, General Use MDM
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ

    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 Halo Shield Flipper Shield Disposable Arm/Femoral Drape Peripheral Shield Modular Toga Z-Friction Drape Anti-Fog Scope Warmer Urological Drain Bag / Uro-Catcher Bag

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Reprocess Single-Use Device