Mondeal

Reusable filter for Sterilisation container L, up to 1000 cleaning & sterilization cycles Ø 190 mm

Registry build 21.09.26
105manufacturers in China registered for this device type
190catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Mondeal
Listed by Mondeal Medical Systems GmbH, Netherlands
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2017-06-26
Record revised 2023-04-04 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Distribution end date 2021-12-31

Catalogue Numbers

Catalogue numbers for Mondeal
Catalogue number Size Status
75-TC3-0677-5 Withdrawn
76-TB4-3106 Withdrawn
75-TC3-0677-12 Withdrawn
75-TC2-0985 Withdrawn
75-TC3-0677-125 Withdrawn
75-TC3-0677-9 Withdrawn
75-TC2-0979 Withdrawn
75-TC2-0953 Withdrawn
76-TB1-1100 Withdrawn
77-TE9-0001 Withdrawn
27-TB4-4002 Withdrawn
75-TC3-0677-45 Withdrawn
75-TC2-0970 Withdrawn
75-TC3-0677-7 Withdrawn
77-TC1-0948 Withdrawn
75-TC3-0677-10 Withdrawn
75-TC2-0983 Withdrawn
75-TC3-0677-75 Withdrawn
76-TB7-2400 Withdrawn
27-TB4-1001 Withdrawn
75-TC3-0677-2 Withdrawn
75-TC3-0677-36 Withdrawn
75-TB7-4000 Withdrawn
27-TB4-4004 Withdrawn
76-TB4-3100 Withdrawn
77-TC1-0943 Withdrawn
75-TB2-2001 Withdrawn
75-TC3-0677-52 Withdrawn
27-TB4-4001 Withdrawn
75-TC2-0962 Withdrawn
75-TC3-0677-95 Withdrawn
76-TB4-3105 Withdrawn
76-TB1-2100 Withdrawn
75-TC2-0965 Withdrawn
75-TB1-1001 Withdrawn
75-TC2-0949 Withdrawn
75-TC3-0677-58 Withdrawn
75-TC3-0677-100 Withdrawn
77-TG0-0001 Withdrawn
77-TC1-0925 Withdrawn
75-TC2-0958 Withdrawn
75-TC2-0946 Withdrawn
77-TA2-2201 Withdrawn
77-TC1-0932 Withdrawn
27-TA4-1002 Withdrawn
77-TA4-2002 Withdrawn
75-TC2-0957 Withdrawn
27-TA4-1001 Withdrawn
75-TC3-0677-48 Withdrawn
75-TC2-0942 Withdrawn
75-TC2-0960 Withdrawn
75-TC2-0950 Withdrawn
75-TC3-0677-16 Withdrawn
27-TB4-2001 Withdrawn
76-TB2-2000 Withdrawn
77-TC1-0923 Withdrawn
27-TC1-0923M1 Withdrawn
27-TC1-0922M2 Withdrawn
75-TC2-0973 Withdrawn
75-TC2-0968 Withdrawn
75-TC3-0677-115 Withdrawn
75-TC3-0677-70 Withdrawn
75-TC3-0677-13 Withdrawn
75-TA2-1001 Withdrawn
77-TA4-2001 Withdrawn
76-TB4-3108 Withdrawn
75-TC2-0986 Withdrawn
75-TC3-0677-40 Withdrawn
77-TC1-0944 Withdrawn
75-TC2-0984 Withdrawn
75-TC3-0677-46 Withdrawn
75-TC2-0963 Withdrawn
27-TC1-0923M3 Withdrawn
75-TC3-0677-32 Withdrawn
75-TC2-0982 Withdrawn
77-KT1-001 Withdrawn
75-TC3-0677-22 Withdrawn
75-TC3-0677-90 Withdrawn
75-TC3-0677-4 Withdrawn
75-TC3-0677-55 Withdrawn
75-TC2-0943 Withdrawn
76-TB4-3101 Withdrawn
77-TC1-0945 Withdrawn
77-TG0-0002 Withdrawn
77-TC1-0901 Withdrawn
75-TC3-0677-15 Withdrawn
75-TB2-1001 Withdrawn
75-TC3-0677-24 Withdrawn
27-TB4-4003 Withdrawn
75-TC3-0677-6 Withdrawn
77-TC1-0930 Withdrawn
75-TC3-0677-140 Withdrawn
75-TC2-0941 Withdrawn
77-TC1-0934 Withdrawn
27-TC1-0923M2 Withdrawn
27-TC1-0922M1 Withdrawn
75-TC3-0677-120 Withdrawn
75-TC2-0947 Withdrawn
76-TB4-3102 Withdrawn
77-TC1-0931 Withdrawn
75-TC3-0677-14 Withdrawn
75-TC3-0677-11 Withdrawn
27-TB5-2002 Withdrawn
27-TB4-4005 Withdrawn
27-TB5-2004 Withdrawn
75-TC3-0677-3 Withdrawn
77-TC1-0941 Withdrawn
75-TC2-0975 Withdrawn
75-TC3-0677-34 Withdrawn
75-TB1-1002 Withdrawn
75-TC2-0974 Withdrawn
76-TB7-3400 Withdrawn
76-TB4-3103 Withdrawn
76-TB7-2200 Withdrawn
75-TC3-0677-65 Withdrawn
75-TC2-0952 Withdrawn
75-TC3-0677-28 Withdrawn
27-TB5-1002 Withdrawn
75-TC3-0677-38 Withdrawn
75-TC3-0677-60 Withdrawn
75-TC2-0961 Withdrawn
75-TC2-0971 Withdrawn
77-TC1-0940 Withdrawn
76-TB6-3401 Withdrawn
75-TC2-0966 Withdrawn
75-TC2-0969 Withdrawn
27-TB5-2003 Withdrawn
27-TA4-1003 Withdrawn
75-TC2-0972 Withdrawn
75-TB4-4001 Withdrawn
75-TC3-0677-105 Withdrawn
77-TA1-2001 Withdrawn
75-TC2-0944 Withdrawn
77-TA1-3001 Withdrawn
75-TC3-0677-54 Withdrawn
75-TC3-0677-50 Withdrawn
27-TB4-1002 Withdrawn
77-TC1-0924 Withdrawn
75-TC3-0677-130 Withdrawn
77-TC1-0926 Withdrawn
77-TC1-0942 Withdrawn
75-TC3-0677-8 Withdrawn
27-TB5-4001 Withdrawn
75-TC3-0677-42 Withdrawn
76-TB7-3200 Withdrawn
75-TC3-0677-110 Withdrawn
75-TA1-1001 Withdrawn
76-TB6-3402 Withdrawn
77-TE7-2001 Withdrawn
27-TC1-0921 Withdrawn
75-TC2-0977 Withdrawn
75-TC2-0945 Withdrawn
77-TC1-0922 Withdrawn
75-TC2-0959 Withdrawn
27-TC1-0922M4 Withdrawn
75-TC3-0677-85 Withdrawn
75-TC3-0677-18 Withdrawn
75-TC3-0677-135 Withdrawn
75-TC2-0981 Withdrawn
76-TB6-3400 Withdrawn
76-TB4-3104 Withdrawn
75-TC3-0677-30 Withdrawn
77-TC1-0935 Withdrawn
77-TC1-0933 Withdrawn
77-TC1-0936 Withdrawn
75-TC3-0677-44 Withdrawn
77-TC1-0937 Withdrawn
77-TA4-3002 Withdrawn
75-TF1-1002 Withdrawn
75-TC3-0677-80 Withdrawn
27-TB5-2001 Withdrawn
27-TB5-1001 Withdrawn
75-TC2-0964 Withdrawn
75-TB7-2001 Withdrawn
76-TB4-3107 Withdrawn
77-TC1-0947 Withdrawn
75-TB7-4001 Withdrawn
75-TC3-0677-20 Withdrawn
75-TC3-0677-25 Withdrawn
77-TC1-0921 Withdrawn
75-TC3-0677-26 Withdrawn
75-TC3-0677-35 Withdrawn
77-TA4-3001 Withdrawn
27-TC1-0922M3 Withdrawn
75-TC2-0967 Withdrawn
76-TB4-3109 Withdrawn
77-TE7-2002 Withdrawn
77-TC1-0946 Withdrawn
77-TC1-0920 Withdrawn
75-TC3-0677-56 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

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