Elmed

Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, Complete Set of (10)- consisting of…

Registry build 21.09.26

Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, Complete Set of (10)- consisting of 12Fr. 14Fr. 16Fr. 18Fr. 20Fr. 22Fr. 24Fr. 26Fr. 28Fr. 30Fr. Autoclavable Medical Grade Stainless Steel.

5manufacturers in China registered for this device type
233catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KOA
Manufacturer City Province Registered as Device types
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Xiamen HOY Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Elmed
Listed by Elmed, Inc., United States
FDA product code KOA
Device type Surgical Instruments, G-U, Manual (And Accessories)
Device class Class 1
Regulation 21 CFR 876.4730
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-04-24
Record revised 2025-10-03 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2025-10-02
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Elmed
Catalogue number Size Status
ST31400026 In distribution
31534-81 In distribution
ST3136060 In distribution
ST315508 In distribution
ST3154023 In distribution
31070-39 39 In distribution
31400-43 In distribution
ST3127056 In distribution
ST311401011 In distribution
31-4000-24 In distribution
ST3140080 In distribution
ST3140032 In distribution
ST315503 In distribution
31-4000-30 In distribution
31534-33 In distribution
ST3140021 In distribution
ST31791001 In distribution
51270-16A In distribution
ST31935014 In distribution
31-55-01-01 In distribution
30-760 In distribution
31-50-01 In distribution
ST3153431 In distribution
51-4080-06 In distribution
31340-50 In distribution
ST31935010 In distribution
ST3154022 In distribution
31-9350-13 In distribution
51500-44 In distribution
ST31791005 In distribution
67206-10 In distribution
51-4005-22 In distribution
31-50-00 In distribution
ST315504 In distribution
51270-16B In distribution
30036-180 In distribution
51-4005-24 In distribution
31560-23SY In distribution
31270-56 In distribution
31-1401-011 In distribution
ST314028 In distribution
31-2240 In distribution
ST31400014 In distribution
31540-51 In distribution
31070-3953 In distribution
ST30036230 In distribution
31-40-28 In distribution
51-4005-32 In distribution
ST3153432 In distribution
31-4000-22 In distribution
31400-23A In distribution
83-31000-CC In distribution
ST51400510 In distribution
31540-23 In distribution
ST31400022 In distribution
31-40-20 In distribution
31-55-09 In distribution
EL-GU8740 In distribution
ST3156023 In distribution
51-4005-12 In distribution
ST3132851 In distribution
31-4000-20 In distribution
51-4005-10 In distribution
31534-32 In distribution
ST3153438 In distribution
31-40-24 In distribution
ST3129488 In distribution
ST31310021 In distribution
ST51400518 In distribution
51-1100 In distribution
31-4232 In distribution
31534-38 In distribution
ST314022 In distribution
13-CG0823 In distribution
ST3129486 In distribution
51-4230 In distribution
31-40-30 In distribution
ST311401012 In distribution
31540-22 In distribution
31400-21 In distribution
31-A0122.3 In distribution
ST3174021 In distribution
ST315000 In distribution
ST31400012 In distribution
31400-32 In distribution
ST3156022SY In distribution
ST3132821 In distribution
ST312240 In distribution
ST31400016 In distribution
ST31400024 In distribution
ST315502 In distribution
31560-51 In distribution
31-9350-10 In distribution
31-9350-11 In distribution
51500-33 In distribution
ST3133432 In distribution
31-T1009.1 In distribution
ST3157060SYRINGE In distribution
31-40-26 In distribution
31-9350-14 In distribution
31-3580-29A3 In distribution
ST31935012 In distribution
ST3153481 In distribution
31430-01 In distribution
31-A3165.7 In distribution
ST3157814 In distribution
ST31358029A3 In distribution
ST31400185 In distribution
31-A3166.7 In distribution
ST31935011 In distribution
ST30020F70 In distribution
31545-02 In distribution
ST315501 In distribution
F9922 FS In distribution
67206-08 In distribution
31791-001 In distribution
31791-005 In distribution
31570-23 In distribution
ST31935009 In distribution
51-4005-08 In distribution
31328-51 In distribution
ST3156023SY In distribution
31-0124 In distribution
31-T1001.7 In distribution
ST13CG0823 In distribution
ST315505 In distribution
30-761 In distribution
31300-66A In distribution
ST310703939 In distribution
ST3156051 In distribution
ST315507 In distribution
31300-66B In distribution
31734-36 In distribution
31560-33 In distribution
ST30036180 In distribution
ST314024 In distribution
ST31935008 In distribution
31220-32 In distribution
31-4000 In distribution
ST3153451 In distribution
P31270-00HD-220 In distribution
31-50-30 In distribution
51-4005-36 In distribution
ST3154051 In distribution
31-4000-18 In distribution
ST315500 In distribution
31-50-05 In distribution
ST315005 In distribution
31-5781-4 In distribution
31540-31 In distribution
30036-230 In distribution
ST314030 In distribution
ST31400028 In distribution
31-9350-12 In distribution
31360-60 In distribution
31-40-18 In distribution
51-4005-16 In distribution
51-4005-26 In distribution
31340-23 In distribution
31534-51 In distribution
ST51400516 In distribution
ST315509 In distribution
31540-21 In distribution
31220-22 In distribution
51-4005-34 In distribution
ST315001 In distribution
31070-35 35 In distribution
ST31400020 In distribution
51-4005-40 In distribution
31-4000-16 In distribution
31430-03 In distribution
31560-22SY In distribution
31740-21 In distribution
31-4000-14 In distribution
31560-23 In distribution
31400-185 In distribution
31-40-16 In distribution
51-4005-30 In distribution
51-4005-28 In distribution
ST310124 In distribution
51-4005-18 In distribution
ST310703535 In distribution
ST31400030 In distribution
ST3157023 In distribution
51-4005-14 In distribution
31340-20 In distribution
ST314016 In distribution
ST319350 In distribution
ST314020 In distribution
31540-20 In distribution
ST314000 In distribution
ST310703953 In distribution
F9924 FS In distribution
ST31935013 In distribution
31570-60-SYRINGE In distribution
42-4162-70 In distribution
31430-00 In distribution
ST31400018 In distribution
31-2948-6 In distribution
31-4000-26 In distribution
313100-21 In distribution
31400-23B In distribution
31400-80 In distribution
31-A0121.3 In distribution
31340-24 In distribution
31-4000-12 In distribution
ST311401013 In distribution
ST31550101 In distribution
31328-21 In distribution
30020F-70 In distribution
31-9350 In distribution
31334-32 In distribution
31-2948-8 In distribution
ST314018 In distribution
31-4000-28 In distribution
ST314232 In distribution
31534-31 In distribution
31110-14 In distribution
31700-22 In distribution
ST314026 In distribution
31-A3160.7 In distribution
ST3153433 In distribution
31-9350-09 In distribution
31-9350-08 In distribution
ST315506 In distribution
51-4005-20 In distribution
31340-22 In distribution
31-40-22 In distribution
31-A3163.7 In distribution
ST30761 Withdrawn
31400-43 Withdrawn
ST3155TR Withdrawn
ST30760 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 64
Elmed Incorporated Elmed, Inc. 58
Ambler Surgical Ambler Surgical, LLC 35
Greenwald Surgical Company, Inc. Grace Manufacturing Inc 33
Cardinal Health Cardinal Health 200, LLC 30
Novo Surgical Novo Surgical, Inc. 29
Novo Surgical Inc. Novo Surgical, Inc. 23
LHB Industries The Lighthouse For the Blind, Inc. 15
Zoll-Dental Zoll-Dental 13
Gyrus Acmi Gyrus Acmi, Inc. 13
Cook Cook Incorporated 8
Quinelato Schobell Industrial Ltda 7

Showing 12 of 74. All products under Surgical Instruments, G-U, Manual (And Accessories)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer