FDA.reportPublic FDA data

WUXI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30054779903005477990Wuxi Weigher Factory Co. Ltd.1N2026-01-01Majiaqiao Guangyi Wuxi City Jiangsu CN 214011
30055377333005537733WUXI TP ORTHODONTICS MATERIAL CO., LTD.1N2026-01-01L2, A2 BUILDING, LIYUAN ECONOMIC DEVELOPMENT ZONE WUXI Jiangsu CN 214072
30060560443006056044Wuxi Kaishun Medical Device Manufacturing Co., Ltd1N2026-01-01NO. 90 Eaststreet Zhangjing, Xibei Town Xishan District Wuxi Jiangsu CN 214194
30093028203009302820WUXI NEST BIOTECHNOLOGY CO., LTD1N2026-01-01No. 530, Xida Road, Meicun Industrial Park, Xinwu District Wuxi Jiangsu CN 214112
30097544193009754419WUXI FUN GLOVES CO., LTD1N2026-01-01Wuqincun Shitangwan Luoshe Town Huishan District Wuxi Jiangsu CN 214185
30125260023012526002WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD.1N2026-01-01No.136 Mashan Meiliang Road,Binhu Wuxi Jiangsu CN 214092
30140028833014002883WUXI VISION PRO LTD1N2026-01-01Floor 1 Buliging 17, Software Park 29 Lianze Road Wuxi Jiangsu CN 214125
30143149453014314945WUXI SUNMAXX TECHNOLOGY CO.,LTD1N2026-01-01Dize Bridge, Ehu Village, Ehu Town, Xishan District Wuxi Jiangsu CN 214116
30196045553019604555WUXI WISEU IMP&EXP CO., LTD1N2026-01-01No. 168, Chengnan Rd. Xinwu Dist., Wuxi Jiangsu CN 214028
30210231323021023132WUXI LYUSMILE IMP AND EXP CO.,LTD1N2026-01-01Suite 2509, No.990,Western Jianghai Rd. Wuxi,214073,Jiangsu Province ,China WUXI Jiangsu CN 214073
30302341673030234167WUXI XINDI MEDICAL TECHNOLOGY CO., LTD1N2026-01-01No.60, Xinfeng Road, Meicun Town, Xinwu District Wuxi City Jiangsu CN 214000
00WUXI MTFIX GARMENT TECHNOLOGY CO. LTD.5N2020-04-25986-18 Liangxi Road, Binhu District Wuxi Jiangsu CN 214100
00WUXI YOUFEN TECHNOLOGY CO.,LTD.5N2020-04-25Room 635, Junzhuan Pioneer Park No.888, Hongqiao Road Binhu Distirct Wuxi Jiangsu CN 214072
00WUXI PENGYUAN CLOTHING CO., LTD.5N2020-04-25152 Renmin Rd., Gushan Town Jiangyin Jiangsu CN 214413
00WUXI SBAMY INTERNATIONAL TRADING CO.,LTD5N2020-04-25no 151.Chun Hui road, xishan, auxiliary wuxi Jiangsu CN 214101
00WUXI YUANYI TEXTILE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LT5N2020-04-25NO.2 XIANFENG EAST ROAD, ZHAQIAO NEW CENTURY INDUSTRIAL PARK, AN Wuxi Jiangsu CN 214104
00WUXI WANGER TECHNOLOGY CO., LTD.5N2020-04-25No. 282-1, Xigang East Road, Xibei Town, Xishan District Wuxi Jiangsu CN 214000
00WUXI WEIERSI ELECTRONICS CO., LTD5N2020-04-25No.158, donglang Road, Yangjian Town, Xishan District Wuxi Jiangsu CN 214000
00WUXI YOUJIA NON-WOVEN TECHNOLOGY CO., LTD5N2020-04-25Xibei Town Industrial Park, Xishan District, Wuxi City, Jiangshu Wuxi Jiangsu CN 214000
00WUXI WELLPRAY MEDICAL DEVICE CO. LTD5N2020-04-25Economic and technological development park Yixing City Jiangsu CN 214200
00WUXI XINGCHU MEDICAL TECHNOLOGY CO.LTD5N2020-04-254th floor,Building No.30-10,Huixi Road,Liangxi District Wuxi Jiangsu CN 214046
00Wuxi JiuChengTong Rubber Trading Co., Ltd5N2020-04-2528 qinsheng road, DonggangTown, Xishan District Wuxi Jiangsu CN 214199
00WUXI BAXI INTELLIGENT TECHNOLOGY CO., LTD.5N2020-04-25No.90, Yougu Industrial Park, No.58 Jinghong Road Xibei Town, Xishan District Wuxi Jiangsu CN 214194
00WUXI CHENYUHAO POLYMER MATERIAL CO., LTD.5N2020-04-25No. 6, Yanyu Road, Yanqiao Supporting Area, Huishan Economic Dev Wuxi City Jiangsu CN 214000
00Wuxi Haoya Microfiber Technology Co., Ltd.5N2020-04-252-2 Jingshi Road, Xibei Town, Xishan District Wuxi Jiangsu CN 214194

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1406332069036516K950992CERAMAFLEX BRACKET SYSTEMNJM1995-05-03
1406331959460554K780619PREFORMED TOOTH POSITIONERKMY1978-06-28
2580791879182162K240961Disposable Pen Injector AssemblyFMF2024-08-15
2580791271053942K240774Pen InjectorFMF2024-06-18
1922152034905910K161533A1C EZ Glycohemoglobin Analysis SystemLCP2017-06-16
2480391012589335
2580791063284383
2466911110536672
2582401147926176
2473901155974129
1092121155986470
2580791281092089
2495801293252802
2545781365870135
2580791406824411
2420061442904660
2551651560049865
2420061566137336
2580791709800570
2580791733672338
2591101754423387
2473901771345019
2473901783425305
1092121802685999
2420061805104347
2597451805751480
2520811907657402
1092121920391277
2299271942859186
2511551967133396
1092121987035983
2557492017185273
2511412036156253
2580792065686727
2580791000563845
2580791010001878
2975151011095722
2975151051420105
2975151056728671
2032881058208698
2580791062005019
1406331078158144
2975151081724364
2975151111454876
2975151124719173
2975151126256602
2580791129289615
2975151149775196
2803351151200022
2975151154847766
2975151165399411
1406331189295769
2975151203854285
3230821213527807
2032881238445829
2975151271068738
1443311273925644
2975151278812365
2975151282352002
2975151308543967
2975151329925312
2975151332250412
2975151335263006
1406331345573890
2975151358872859
2975151364545149
2975151366838609
2975151394708836
2967041395606312
2975151399976528
2975151420094023
2975151445347582
2975151449888094
2975151466998389
2032881469132181
2975151469350773
2975151470349107
3230821478133233
1406331489112295
3230821512286160
2975151542783564
2975151553340499
2975151561588350
2975151567496461
2975151568414615
2975151581670459
2975151590543370
1443311595983500
2975151620898281
2975151652538958
3230821662512059
2975151671898484
2975151679172184
2975151693010635
2975151696851415
2975151703916358
1922151715707641
2967041725864790
2580791740607838
2975151742184631
1443311751259827
1406331798983444
2975151806225108
2580791806558338
2032881817734823
2975151826178200
2975151827244813
2975151852439311
2975151856950902
2580791868832486
2967041873318452
2975151887661983
2975151889302134
2975151889699278
2975151910217953

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF22024-08-15
LCP12017-06-16
NJM11995-05-03
KMY11978-06-28

NDC#

PMN#

Clear Aligner

2023-06-13

Wuxi EA Medical Instruments Technologies Limited.

Clear Aligner

2021-10-08

Wuxi EA Medical Instruments Technologies Limited.

JIAJIAN TENS

2012-05-02

WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.

Applications#

GUDID#

BioHermes Glycohemoglobin Quality Control - Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (glycohemoglobin analyzers and test kits) with the methodology of boronate affinity chromatography, manufactured by Wuxi BioHermes Bio & Medical Technology Co.,Ltd.. Contents: Level 1: 5 vials x 50uL; Level 2: 5 vials x 50uL; Package Insert×1.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

2022-08-26

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