FDA.report

HEB

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30074208423007420842Hebei Fenghe Biotechnology INC.,Ltd1N2026-01-01No. 19 Hexie Street,HTI Zone Handan Hebei CN 056004
30090999273009099927HEBEI HONGTAI PLASTIC PRODUCTS CO.,LTD.1N2026-01-01No 15, Luban Road , Julu county Xingtai Hebei CN 055250
30097091783009709178Hebei Changsheng Plastic Products Co.,Ltd.1N2026-01-01No 99, Huangjin Avenue, Julu County xingtai Hebei CN 055250
30097501213009750121HEBEI YIHOUCHENG COMMODITY CO., LTD.1N2026-01-01No.333 Jianye Road Mancheng Baoding Hebei CN 072150
30135647183013564718HEBEI LEAMAI MEDICAL INSTRUMENT CO., LTD.1N2026-01-01No. 888 Kaiyuan Road, Jizhou District Hengshui Hebei CN 053000
30265934403026593440HEBEI FEIFAN BIOTECHNOLOGY CO.,LTD.1N2026-01-01North Of Anxia Village, Zhengding County Shijiazhuang Hebei CN 050800
30273324783027332478HEBEI XINGFANG MEDICAL INSTRUMENTS TECHNOLOGY CO., LTD1N2026-01-01Dongshiduan Village Dongshiduan Town Xushui County BaoDing City Hebei CN 072550
30299951693029995169HEBEI JISUNG MEDICAL EQUIPMENT CO. LTD.1N2026-01-01No.888 Kaiyuan Road, Jizhou District Hengshui City Hebei CN 053200
30305435313030543531HEBEI NEWANGIE TECHNOLOGY CO., LTD1N2026-01-01Room 402, Building A-5, Guoxietang Industrial Park, No. 509 Taih Shijiazhuang Hebei CN 050035
30312331993031233199HEBEI LUFEN TECH CO., LIMITED1N2026-01-01Workshop No. 1, west side of Zhenxing Street and north side of Kaifang Road, Weixian High-tech Industrial Devel Xingtai Hebei CN 065200
30338492613033849261HEBEI JUNLAOLE MEDICAL TECHNOLOGY CO.,LTD1N2026-01-011. South District 3-3-1, No. 888 Kaiyuan Road, Jizhou District 2. North District 5-5 West, No. 999 Kaiyuan Road Hengshui City Hebei CN 053000
30370470603037047060HEBEI KEYLASER SCI-TECH CO., LTD.1N2026-01-014th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road Baoding Hebei CN 072750
30431499023043149902HEBEI TUOSITE TECHNOLOGY CO.,LTD1N2026-01-01Room 2911, Tower A, MixC Mall, Qiaoxi District, Shijiazhuang Hebei CN 050000
30436546603043654660HEBEI JIEDE MEDICAL EQUIPMENT CO., LTD.1N2026-01-01Building 5, Jizhou District Amusement Equipment Entrepreneurship Hengshui Hebei CN 053200
00HEBEI XINYANGYUAN MEDICAL EQUIPMENT CO., LTD.5N2020-04-25Nanmatan Village,Shicun Township,Hejian City Cangzhou Hebei CN 062450
00HEBEI WUAO MEDICAL INSTRUMENT CO., LTD.5N2020-04-251009 Room, 10 Floor, 4 Building, Science Park of Hebei Universit Cangzhou Anhui CN 061000
00HEBEI SHOUZHENG TECHNOLOGY CO., LTD.5N2020-04-25Room 2212, Financial Building, No. 598 Zhongshan East Road, Chan Shijiazhuang Hebei CN 050000
00HEBEI XINYUE PAPER & PLASTIC PACKAGING CO., LTD.5N2020-04-25North of Lijiazhuang Village, Dayue Town, Xinle City Xinle Hebei CN 050701
00HEBEI YIZE MEDICAL EQUIPMENT CO., LTD.5N2020-04-25NO. 66, Meihuating Road, Economic development Zone Xingtai Hebei CN 054001
00HEBEI ANTUO MEDICAL DEVICES CO., LTD.5N2020-04-25Yard No.5, Yongda Road,Wumaying Industrial Park .Nanpi Economic Cangzhou Hebei CN 061599
00HEBEI ZHEGANG TECHNOLOGY CO., LTD.5N2020-04-2589 Yuxiang Street, Equipment Manufacturing Industrial Park, Luan Shijiazhuang Hebei CN 051430
00HEBEI JINGDE MEDICAL DEVICE TECHNOLOGY CO., LTD.5N2020-04-25Fuda Road - Tongsheng Road, Southern Area of Industrial Park, Gu Langfang Hebei CN 065599
00HEBEI JIATANG MEDICAL EQUIPMENT CO., LTD.5N2020-04-25North of Fengying Village, Shengying Town, Guangping County, Handan Hebei CN 057650
00HEBEI HUIKANG COMMODITY CO. , LTD5N2020-04-25WEST XIE VILLAGE YUANSHI COUNTY SHIJIAZHUANG Hebei CN 051130
00HEBEI GUANGHUI JIAYE BIOTECHNOLOGY CO., LTD.5N2020-04-25No. 3, medical device Industrial Park, ZOJE Industrial Park, Boh Cangzhou Hebei CN 061100

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3376891287447645K252519CO2 Laser Therapy System (K106)GEX2025-11-07
3376891243376981K252515Q-Switched Nd:Yag laser (K690)GEX2025-11-06
3255421346008164K252447Picosecond laser device (BMPS4)GEX2025-10-01
3255421068776848K251801Diode laser device (BM091)GEX2025-08-08
3467001868679389K242186Neo Sculptor (OF-NEO001)NGX2024-09-17
3376891956316929K241498Diode laser Treatment System (K18)GEX2024-11-18
3467001761252446K202257Dermatological Diode Laser SystemsGEX2021-04-23
3277711113514482K191970Diode Laser Hair Removal SystemGEX2020-04-06
1291411797226462K163168Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)LYZ2017-02-23
1430981539895830K113837POWDER FREE VINYL PATIENT EXAMINATION GLOVESLYZ2012-04-27
1291411100566792K102819POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2010-12-23
1291412019305195K102817POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2010-12-23
2498741017588262
2461491036045766
2496141044284758
2551501137531415
2551501149411523
2461491149646986
2558411249949168
2461491357342482
2496141438109727
2496141454603091
2496141533902182
2559731538641135
2522191568777813
2496141617081525
2558411652467538
2450521700360086
2421111725452197
2551501730593738
2505441803490762
2461491910364553
2496142012872288
2496142033197301
2574182047789295
1567842055237010
2551502058562967
3211981000060673
3467001023578135
965931035344199
3277711042382103
3472851050282344
3467001053654890
3472851061729329
3159191064097945
3472851064816947
3159191070344909
3472851086781338
3328141093597761
3472851095915637
3143171101553207
3467001126400417
3472851126837821
3472851141895562
3472851147527249
3472851161955231
3355281187377988
3328141200490719
3355281221875292
1567841228606408
3159191245717021
3277711256189330
3277711260537930
3467001265152988
3277711271778354
3355281290032550
3472851335930040
3143171341914496
3211981360045192
3467001363451232
3277711385195642
3277711405024983
3211981430788444
3328141471416066
3277711475418494
3277711498119122
3355281505394735
3328141526729963
3328141532890265
3328141533782834
1567841538671207
3467001540988901
3328141541049923
3211981545103855
3328141549968744
3159191562135430
3472851562603299
3472851591637811
3328141602988305
3472851612696646
3277711619695935
3355281639308156
1567841639721608
3159191658182023
3467001669154953
3143171691625351
3328141692468849
3472851700405812
3328141717655248
3467001727798562
3472851749394352
3467001802451935
3328141804684668
3159191804820866
3467001825310782
3277711825910130
3328141879435349
3328141883047140
3472851903645884
3472851904843387
3467001915621400
3328141915938485
3472851916433178
3211981939996471
3472851945998324
3277711947337992
3467001959440542
3211981959824015
3472851967835472
3328141997722354

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GEX72025-11-07
LYZ42017-02-23
NGX12024-09-17

NDC

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

HEB

HEB

Acetaminophen

Cold Flu Severe Day Night

HEB

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride

101 records. Showing 1-40. Next

PMN

Lancet

2022-09-19

Hebei Xinle Sci&Tech Co., Ltd.

Manual Wheelchair

2022-07-21

Hebei Ruilangde Medical Equipment Technology Group Co., Ltd

44 records. Showing 1-40. Next

Applications