BEUDAMED
    FDA Registration Active 🇨🇳 China

    EXACT MEDICAL MANUFACTURING, INC.

    Reg #: 3018781093 · FEI: 3018781093 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    53
    Establishment Types
    7
    Classifications
    17

    Registration Details

    Registration Name
    EXACT MEDICAL MANUFACTURING, INC.
    Registration Number
    3018781093
    FEI Number
    3018781093
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 101 Huashan Road, Xin Bei District
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222460

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

    Proprietary Names

    Tourniquet 34"x24" Paper Filter w/ Foam Gasket SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV Z-Friction Drape Anti-Fog Scope Warmer Intraoperative Probe Cover, Transducer Cover, Probe Cover Syringe, Luer Slip Ice Compression Bandage Ice Pack Hays Innovation Anchor Sound Device Urological Drain Bag / Uro-Catcher Bag EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER SurgiCount®+ Reader Cover SurgiCount®+ Sponge Counting Bag EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES Probe Cover Ultrasound Probe Cover Transducer Cover Ultrasound Cover EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV 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 Dark Drape DX Dark Drape EMM EQUIPMENT COVER-POLYTHYLENE DrillCover - SteriGo Sterile Drapes Autoguide 15 pack Halo Shield Flipper Shield Disposable Arm/Femoral Drape Peripheral Shield Kit, Convenience EMM SURGICAL GOWN-SMS WITH PE LAYER SmokeStop 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 DRAPE SMS W/PE SIDES

    Establishment Types

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