H.E.B.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007420842	3007420842	Hebei Fenghe Biotechnology INC.,Ltd	1	N	2026-01-01	No. 19 Hexie Street,HTI Zone Handan Hebei CN 056004
3009099927	3009099927	HEBEI HONGTAI PLASTIC PRODUCTS CO.,LTD.	1	N	2026-01-01	No 15, Luban Road , Julu county Xingtai Hebei CN 055250
3009709178	3009709178	Hebei Changsheng Plastic Products Co.,Ltd.	1	N	2026-01-01	No 99, Huangjin Avenue, Julu County xingtai Hebei CN 055250
3009750121	3009750121	HEBEI YIHOUCHENG COMMODITY CO., LTD.	1	N	2026-01-01	No.333 Jianye Road Mancheng Baoding Hebei CN 072150
3013564718	3013564718	HEBEI LEAMAI MEDICAL INSTRUMENT CO., LTD.	1	N	2026-01-01	No. 888 Kaiyuan Road, Jizhou District Hengshui Hebei CN 053000
3026593440	3026593440	HEBEI FEIFAN BIOTECHNOLOGY CO.,LTD.	1	N	2026-01-01	North Of Anxia Village, Zhengding County Shijiazhuang Hebei CN 050800
3027332478	3027332478	HEBEI XINGFANG MEDICAL INSTRUMENTS TECHNOLOGY CO., LTD	1	N	2026-01-01	Dongshiduan Village Dongshiduan Town Xushui County BaoDing City Hebei CN 072550
3029995169	3029995169	HEBEI JISUNG MEDICAL EQUIPMENT CO. LTD.	1	N	2026-01-01	No.888 Kaiyuan Road, Jizhou District Hengshui City Hebei CN 053200
3030543531	3030543531	HEBEI NEWANGIE TECHNOLOGY CO., LTD	1	N	2026-01-01	Room 402, Building A-5, Guoxietang Industrial Park, No. 509 Taih Shijiazhuang Hebei CN 050035
3031233199	3031233199	HEBEI LUFEN TECH CO., LIMITED	1	N	2026-01-01	Workshop No. 1, west side of Zhenxing Street and north side of Kaifang Road, Weixian High-tech Industrial Devel Xingtai Hebei CN 065200
3033849261	3033849261	HEBEI JUNLAOLE MEDICAL TECHNOLOGY CO.,LTD	1	N	2026-01-01	1. 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
3037047060	3037047060	HEBEI KEYLASER SCI-TECH CO., LTD.	1	N	2026-01-01	4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road Baoding Hebei CN 072750
3043149902	3043149902	HEBEI TUOSITE TECHNOLOGY CO.,LTD	1	N	2026-01-01	Room 2911, Tower A, MixC Mall, Qiaoxi District, Shijiazhuang Hebei CN 050000
3043654660	3043654660	HEBEI JIEDE MEDICAL EQUIPMENT CO., LTD.	1	N	2026-01-01	Building 5, Jizhou District Amusement Equipment Entrepreneurship Hengshui Hebei CN 053200
0	0	HEBEI XINYANGYUAN MEDICAL EQUIPMENT CO., LTD.	5	N	2020-04-25	Nanmatan Village,Shicun Township,Hejian City Cangzhou Hebei CN 062450
0	0	HEBEI WUAO MEDICAL INSTRUMENT CO., LTD.	5	N	2020-04-25	1009 Room, 10 Floor, 4 Building, Science Park of Hebei Universit Cangzhou Anhui CN 061000
0	0	HEBEI SHOUZHENG TECHNOLOGY CO., LTD.	5	N	2020-04-25	Room 2212, Financial Building, No. 598 Zhongshan East Road, Chan Shijiazhuang Hebei CN 050000
0	0	HEBEI XINYUE PAPER & PLASTIC PACKAGING CO., LTD.	5	N	2020-04-25	North of Lijiazhuang Village, Dayue Town, Xinle City Xinle Hebei CN 050701
0	0	HEBEI YIZE MEDICAL EQUIPMENT CO., LTD.	5	N	2020-04-25	NO. 66, Meihuating Road, Economic development Zone Xingtai Hebei CN 054001
0	0	HEBEI ANTUO MEDICAL DEVICES CO., LTD.	5	N	2020-04-25	Yard No.5, Yongda Road,Wumaying Industrial Park .Nanpi Economic Cangzhou Hebei CN 061599
0	0	HEBEI ZHEGANG TECHNOLOGY CO., LTD.	5	N	2020-04-25	89 Yuxiang Street, Equipment Manufacturing Industrial Park, Luan Shijiazhuang Hebei CN 051430
0	0	HEBEI JINGDE MEDICAL DEVICE TECHNOLOGY CO., LTD.	5	N	2020-04-25	Fuda Road - Tongsheng Road, Southern Area of Industrial Park, Gu Langfang Hebei CN 065599
0	0	HEBEI JIATANG MEDICAL EQUIPMENT CO., LTD.	5	N	2020-04-25	North of Fengying Village, Shengying Town, Guangping County, Handan Hebei CN 057650
0	0	HEBEI HUIKANG COMMODITY CO. , LTD	5	N	2020-04-25	WEST XIE VILLAGE YUANSHI COUNTY SHIJIAZHUANG Hebei CN 051130
0	0	HEBEI GUANGHUI JIAYE BIOTECHNOLOGY CO., LTD.	5	N	2020-04-25	No. 3, medical device Industrial Park, ZOJE Industrial Park, Boh Cangzhou Hebei CN 061100

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
337689	1287447645	K252519	CO2 Laser Therapy System (K106)	GEX	2025-11-07
337689	1243376981	K252515	Q-Switched Nd:Yag laser (K690)	GEX	2025-11-06
325542	1346008164	K252447	Picosecond laser device (BMPS4)	GEX	2025-10-01
325542	1068776848	K251801	Diode laser device (BM091)	GEX	2025-08-08
346700	1868679389	K242186	Neo Sculptor (OF-NEO001)	NGX	2024-09-17
337689	1956316929	K241498	Diode laser Treatment System (K18)	GEX	2024-11-18
346700	1761252446	K202257	Dermatological Diode Laser Systems	GEX	2021-04-23
327771	1113514482	K191970	Diode Laser Hair Removal System	GEX	2020-04-06
129141	1797226462	K163168	Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)	LYZ	2017-02-23
143098	1539895830	K113837	POWDER FREE VINYL PATIENT EXAMINATION GLOVES	LYZ	2012-04-27
129141	1100566792	K102819	POWDER-FREE VINYL PATIENT EXAMINATION GLOVES	LYZ	2010-12-23
129141	2019305195	K102817	POWDER-FREE VINYL PATIENT EXAMINATION GLOVES	LYZ	2010-12-23
249874	1017588262
246149	1036045766
249614	1044284758
255150	1137531415
255150	1149411523
246149	1149646986
255841	1249949168
246149	1357342482
249614	1438109727
249614	1454603091
249614	1533902182
255973	1538641135
252219	1568777813
249614	1617081525
255841	1652467538
245052	1700360086
242111	1725452197
255150	1730593738
250544	1803490762
246149	1910364553
249614	2012872288
249614	2033197301
257418	2047789295
156784	2055237010
255150	2058562967
321198	1000060673
346700	1023578135
96593	1035344199
327771	1042382103
347285	1050282344
346700	1053654890
347285	1061729329
315919	1064097945

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
GEX	7	2025-11-07
LYZ	4	2017-02-23
NGX	1	2024-09-17

NDC

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

enoxaparin sodium

HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented

H.E.B.

Zinc Oxide

nasal

H E B

oxymetazoline hydrochloride

antibiotic

H E B

Neomycin, Polymyxin B, Pramoxine HCl

Omeprazole Magnesium

HEB

Omeprazole Magnesium

Pseudoephedrine Hydrochloride

HEB

Pseudoephedrine Hydrochloride

Allergy

H E B

Diphenhydramine Hydrochloride

Athletes Foot Ultra

H E B

Butenafine Hydrochloride

Infants Non-staining Gas relief

H E B

Simethicone

Petroleum

H E B

White Petrolatum

Nighttime Sleep Aid

HEB

DIPHENHYDRAMINE HYDROCHLORIDE

Diaper Rash

H E B

Zinc oxide

Fexofenadine HCl and Pseudoephedrine HCI

HEB

Fexofenadine HCl and Pseudoephedrine HCI

ibuprofen

H E B

Ibuprofen

Oral Sore Antiseptic

H E B

Hydrogen Peroxide, Menthol

HEB SPF 50 Mineral Sunscreen Stick

H.E.B.

Zinc Oxide

Menthol Cough Drop

HEB

Menthol

Cherry cough drop

HEB

Menthol

HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented

H.E.B.

Zinc Oxide

HEB Calaclear

H E B

Zinc Acetate and Pramoxine Hydrochloride

Acid Controller

H E B

Famotidine

Once Daily Relief

H E B

Olopatadine Hydrochloride Ophthalmic Solution

Naproxen Sodium

HEB

Naproxen Sodium

SF Menthol Cough Drop

HEB

Menthol

Isopropyl

H E B

ISOPROPYL ALCOHOL

night time

H E B

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate

ibuprofen

H E B

ibuprofen

Cherry Antacid Soft Chew

HEB

Calcium Carbonate

Honey Lemon Cough Drop

HEB

Menthol

Mixed Berry Sore Throat and Cough Lozenges

HEB

Benzocaine

MILK OF MAGNESIA

H E B

magnesium hydroxide

All Day Pain Relief

H E B

Naproxen Sodium

Petroleum Skin Protectant

H E B

White Petrolatum

Dandruff

H E B

Pyrithione zinc

200 records. Showing 1-40. Next

PMN

Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)

2022-10-26

Hebei Titans Hongsen Medical Technology Co., Ltd.

Nitrile Exam Gloves (Blue, Black)

2022-08-25

Hebei Astro Medical Supply Co., Ltd.

Manual Wheelchair

2022-07-21

Hebei Ruilangde Medical Equipment Technology Group Co., Ltd

Nitrile Powder Free Examination Gloves

2022-05-18

Hebei Kangxida Medical Technology Development Co., Ltd.

Vinyl Exam Gloves

2022-01-05

Hebei Astro Medical Supply Co., Ltd

Disposable Medical Surgical Mask

2021-08-18

Hebei Titans Hongsen Medical Technology Co., LTD

Vinyl Compound Examination Gloves

2021-07-29

Hebei Titans Hongsen Medical Technology Co., LTD.

Single-use Medical Poly (vinyl Chloride) Examination Glove (Clear, Non-Colored)

2018-09-21

Hebei Titans Hongsen Medical Technology Co., LTD.

Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs

2018-08-10

Hebei Titans Hongsen Medical Technology Co., LTD.

Powder Free Nitrile Patient Examination Gloves, Blue

2017-05-22

HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD.

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)

2017-02-23

HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED

POWDER FREE Blue Nitrile GLOVES, Tested For Use With Chemotherapy Drugs

2017-02-13

HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)

2015-06-18

HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

Powder-free PVC Vinyl Exam Gloves

2015-01-15

Hebei Grandeast Plastic Products Co., Ltd.

POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)

2014-12-22

HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)

2014-08-12

HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

2013-09-25

HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD

VASCULAR CLAMPS

2013-05-14

HEBU MEDICAL GMBH

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

2012-11-30

HEBEI LEADER PLASTIC CO., LTD

POWDER FREE VINYL PATIENT EXAMINATION GLOVES

2012-04-27

HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD.

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

2011-04-28

HEBEI TENGDA PLASTIC CO., LTD

POWDERED VINYL PATIENT EXAMINATION GLOVES

2011-04-27

HEBEI TENGDA PLASTIC CO., LTD

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

2011-01-13

HEBEI FAVOR PLASTIC CO., LTD

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

2010-12-23

HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD.

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

2010-12-23

HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD.

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

2010-08-24

HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

2010-08-06

HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT

POWDERED VINYL PATIENT EXAMINATION GLOVES

2010-07-27

HEBEI EXCELLENT PLASTIC CO., LTD.

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

2010-07-27

HEBEI EXCELLENT PLASTIC CO., LTD.

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

2010-07-16

HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

2010-06-17

HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

2009-02-09

HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

2009-02-04

HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.

POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

2005-06-20

HEBEI MANFUL IMPORT & EXPORT CO., LTD.

Applications

218775

HEBEI CHANGSHAN

202598

HEBEI CHANGSHAN

076692

HEBEI CHANGSHAN

GUDID

ZHEONE - The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Hebei Zhemai Technology Co., Ltd.

2024-09-19

ZHEONE - The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Hebei Zhemai Technology Co., Ltd.

2024-09-19