FDA.reportPublic FDA data

Shandong YZM Intelligent Technology Co., Ltd

Matched from indexed company URL: SHANDON, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
303022235303022235Shandong YZM Intelligent Technology Co., Ltd1N2026-01-01Southeast Corner of Qilujiudi Avenue and Wenshui North Road, Anq weifang Shandong CN 262100
30037231763008801456SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD.1N2026-01-01No.1 Shuangshan Sanjian Road, Zhangqiu JINAN Shandong CN 250200
30070845753007084575ShanDong WeiGao Group Medical Polymer Co., Ltd1N2026-01-01No.1 Weigao Road, Torch Hi-tech Science Park Weihai Shandong CN 264210
30077070043007707004SHANDONG HUAYUE GLOVE CO., LTD.1N2026-01-01East of Yifan Rd. and North of Naqi Rd. Science and Technology Based Ind. Zone Zibo Shandong CN 255400
30097418333009741833SHANDONG ZHIYUAN MEDICAL PRODUCT CO LTD1N2026-01-0120 Shengshui Rd. Mihe Industry Park Qingzhou Shandong CN 262519
30103750763010375076Shandong Chengsheng Healthcare Products co.,Ltd1N2026-01-01No.2727 Shimen Road, Chengguan Street, Linqu County Weifang Shandong CN 261000
30113914333011391433SHANDONG INTCO MEDICAL PRODUCTS CO LTD1N2026-01-019888 Qiwang Road Naoshan Industrial Park Qingzhou Shandong CN 262500
30120392633012039263Shandong Ande Healthcare Apparatus Co., Ltd.1N2026-01-01No. 999, Zunxian Road, New & Hi-Tech Zone, Zibo Shandong CN 255086
30124611273012461127SHANDONG CAREMED MEDICAL PRODUCTS CO.,LTD.1N2026-01-01YanTai Industrial Park, Ding Tao Country East of Zhanqian Road Heze Shandong CN 274100
30134274453013427445SHANDONG HENGFA HYGIENIC PRODUCTS CO.,LTD.1N2026-01-01Fengyang Village,Jinhaozhuang Township, Linqing City,liaocheng City, Shandong CN 252600
30134513673013451367SHANDONG XINGYU GLOVES CO., LTD1N2026-01-01No.2158,Yaoqian Road,Economic Development Zone Gaomi Shandong CN 261502
30134611943013461194SHANDONG TRANLIN STRAW NEW ENVIRONMENTAL TECHNOLOGY JOINT STOCK COMPANY LIMITED1N2026-01-01No.15, Guangming East Road, Gaotang County LIAOCHENG Shandong CN 252800
30134968673013496867SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD1N2026-01-01South Fanlou Road Shan County Development Zone Heze Shandong CN 274300
30146665793014666579SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.1N2026-01-01Huiquan East Road, Shizhong District, Zaozhuang City, Shangdong Zaozhuang Shandong CN 277117
30154124663015412466SHANDONG HENGYA PACKAGING PRINTING CO.,LTD1N2026-01-01Hetou village, Yingqiu town, Changle county, Weifang Shandong CN 262416
30154776493015477649SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD1N2026-01-01NORTH ROAD, FUMIN AVENUE,QINGHE STREET, CAOXIAN COUNTY HEZE CITY Shandong CN 274400
30158750063015875006SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD1N2026-01-01North Road, Fumin Avenue,Qinghe Street, Caoxian County Heze City Shandong CN 274400
30169206403016920640SHANDONG FENGAO MEDICAL TECHNOLOGY CO., LTD.1N2026-01-01Room 12, Instrument industry park No.9009,Qinglongshan Road High-tech Zone Zibo Shandong CN 255000
30170795263017079526SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD.1N2026-01-01North of xinwuroad, West of gaojiuroad, High-Tech Industrial Development Zone Binzhou Shandong CN 256600
30172357783017235778SHANDONG ANSEN HEALTHCARE PRODUCTS CO.,LTD1N2026-01-01BAICHANG VILLAGE,LIZHUANG TOWN,TANCHENG DISTRICT,LINYI,SHANDONG Linyi Shandong CN 276000
30212457393021245739SHANDONG RICHSOURCE BIOLOGICAL TECHNOLOGY CO.,LTD1N2026-01-0150m to the South of Miaokou Village, Yangdian Town, Wenshang Cou Jining Shandong CN 272500
30225434783022543478SHANDONG BLUE SAIL HEALTH TECHNOLOGY CO., LTD1N2026-01-01No.1888 Longshan Road, Longshan Advanced Technology Industry Park, Linq Weifang Shandong CN 262600
30273354923027335492SHANDONG LIANGYUE MEDICAL DEVICE TECHNOLOGY CO.,LTD1N2026-01-01Building A4, Tancheng Hi-Tech Electronics Industrial Park, Qings LinYi Shandong CN 276100
30275177173027517717SHANDONG KANG HU SHI SANITARY PRODUCTS CO., LTD1N2026-01-01Jinling textile factory compound at the junction of Jun Bu Stree Linyi Shandong CN 276000
30299702393029970239SHANDONG DEMAN MEDICAL EQUIPMENT GROUP CO., LTD1N2026-01-01Xiaomeng Town Industrial Park, Yanzhou District Jining City Shandong CN 272100

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2429741681331097K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)LZA2024-04-01
2291761173987420K233182Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)LZA2023-12-15
1805141587763448K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)LYY2023-02-22
2291761211686408K222815Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and FentanylLZA2022-12-04
2127671756033715K222766Disposable Extension SetFPA2024-04-12
207771038304851K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceQRL2022-11-30
207771177645550K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)FMK2022-10-03
1040131108937535K222074Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination GlovesLZA2022-10-17
3038661342593258K220228Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy DrugsLZA2022-03-18
2127671582121405K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose ImmunizationMEG2022-10-07
1805142028796493K213509Latex Examination Gloves, Powder FreeLYY2022-04-08
1983782038517205K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needleFMF2022-08-17
2127671910310893K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety NeedlesMEG2022-03-01
2438421576554036K210780Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)LYZ2021-05-14
2438421955386169K210779Powder Free Nitrile Patient Examination Gloves, Blue ColorLZA2021-11-10
2931841546653756K210777Powder Free Nitrile Patient Examination Gloves, Blue ColorLZA2021-11-02
2931841698719271K210774Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)LYZ2021-05-14
1983781677003676K2107723-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)FXX2021-09-22
1983781506185108K210510Disposable Surgical GownFYA2021-08-12
1983781325314004K203454Infrared ThermometerFLL2021-04-29
1983781997842132K203439Disposable Vinyl Examination GlovesLYZ2021-02-26
1983781515769838K203436Disposable Nitrile Examination GlovesLZA2021-04-28
1805141753142523K202708Surgical Face MasksFXX2021-03-30
2127671952032373K202060Disposable IV catheterFOZ2021-07-23
2127671921768795K201460Closed System Transfer DeviceONB2022-11-23
2127671727909670K193657Disposable Enteral Feeding Syringe with Enfit ConnectorPNR2020-09-12
2203971678449903K192560Surgical GownFYA2020-05-22
2291761312183203K182640Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)LZA2019-04-12
2429741830845490K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorLZA2017-07-20
2429741909173050K171615Xingyu Nitrile Powder Free Patient Examination Gloves, White colorLZA2017-07-31
1040131462477684K170393Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)LZA2017-05-09
1805141879658810K170136Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsLZA2017-08-25
2127671517998568K162601Infusion Set for Single UseFPA2017-05-31
1503291860900380K153028Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueLYZ2016-02-05
1878281053852773K152824MEDT PEN NEEDLEFMI2016-03-07
1878281449190174K152808U&U Insulin Syringe with/without Safety Retractable DeviceMEG2016-03-25
1878281137973791K151151U & U Intravascular Administration SetFPA2015-09-24
1805141198927465K142892Powder-free Clear Vinyl Patient Examination GlovesLYZ2015-03-25
1878281120876360K142765TM SAFETY NEEDLEFMI2015-08-11
1878281694375214K132553U&U STERILE PISTON SYRINGE WITHOUT NEEDLEFMF2014-02-27
1878281853273623K132552U&U STERILE HYPODERMIC NEEDLEFMI2013-11-13
1805141468940330K131832POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2014-01-07
1503291470739757K112266POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLORLYZ2012-05-08
1805141693006391K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
2291761743013450K110314STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)LYZ2011-05-10
1503292016295561K102444POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2010-11-22
1040131061184670K090520STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)LYZ2009-05-18
1040131757008729K090513VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)LYZ2009-05-08
895532071885780K082439DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CTDXT2009-03-23
895531435199795K073127BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22GFMI2007-12-20
1805141736697688K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZA2002-10-11
1878281026751393
2429741284365449
2429741743084251
1878281902269260
207771928064003
2429742048929167
1983781010786707
2983781027224013
1555571033131849
1983781049995436
1983781054855715
2203971057677709
1983781058944991
3469751076438082
1983781088513361
1983781094549740
1983781096741871
2203971102350620
2203971103858617
2606931104239859
1983781105631934
1983781109204832
1983781127339411
1983781133217394
1983781137402551
1983781139554737
1555571144059325
2203971156551732
2890821161198359
1983781173236126
1983781188644425
1983781193716628
1983781194353690
3172151196296621
1983781199629313
1983781212869674
2983781213728960
1998581214283275
1983781219173260
1983781221922266
1555571234082183
2288981236394956
1555571238256298
2203971240179766
1983781240721530
1983781241402428
2890821257103228
1983781261482464
3161011269896587
3208791274722399
1983781280993671
895531292313201
3208791295565666
2203971304093439
1555571307928622
2983781314775653
1983781322753167
2203971328548199
1983781335248894
1998581358625969
1983781358856356

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA162024-04-01
LYZ112021-05-14
FMI72016-03-07
FPA42024-04-12
MEG42022-10-07
FMF32022-08-17
LYY22023-02-22
FXX22021-09-22
FYA22021-08-12
QRL12022-11-30
ONB12022-11-23
FMK12022-10-03
FOZ12021-07-23
FLL12021-04-29
PNR12020-09-12
DXT12009-03-23

NDC#

Sevoflurane

Shandong New Time Pharmaceutical Co., Ltd.

Sevoflurane

Isoflurane

Shandong New Time Pharmaceutical Co., Ltd.

Isoflurane

Isoflurane

Shandong New Time Pharmaceutical Co., Ltd.

Isoflurane

oxaliplatin

Shandong New Time Pharmaceutical Co., Ltd.

oxaliplatin

oxaliplatin

Shandong New Time Pharmaceutical Co., Ltd.

oxaliplatin

Rykindo

Shandong Luye Pharmaceutical Co., Ltd.

Risperidone

Rykindo

Shandong Luye Pharmaceutical Co., Ltd.

Risperidone

Rykindo

Shandong Luye Pharmaceutical Co., Ltd.

Risperidone

Alcohol Wipes

Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.

Ethyl Alcohol

Baby Wipes

Shandong Yayun Sanitary Products Co., Ltd.

Propylene Glycol

Pet wipes

Shandong Yayun Sanitary Products Co., Ltd.

Benzalkonium chloride

Alcohol Pads

Shandong Lianfa Medical Plastic Products CO.,LTD

ISOPROPYL ALCOHOL

47 records. Showing 1-40. Next

PMN#

107 records. Showing 1-40. Next

Applications#

219583

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

216534

SHANDONG NEW TIME PHARMACEUTICAL CO LTD

212849

SHANDONG LUYE PHARMACEUTICAL CO LTD

GUDID#

Epredia - The E1000 Dx Digital Pathology Solution is a high-capacity, automated whole slide imaging system for the creation, viewing, and management of digital images of surgical pathology slides. It allows whole slide digital images to be viewed on a display monitor that would otherwise be appropriate for manual visualization by conventional brightfield microscopy.The E1000 Dx Digital Pathology Solution consists of the following three components:Scanner component:E1000 Dx Digital Pathology Scanner with E1000 firmwareE1000 Dx Scanner SoftwareViewer component:E1000 Dx Image Management System (IMS) ServerE1000 Dx Viewer SoftwareDisplay component:Barco MDPC-8127

SHANDON DIAGNOSTICS LIMITED

2025-03-10

80 records. Showing 1-40. Next