Home Aide Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Home Aide Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006899020
• FEI Number: 3006899020
• Name: HUAIAN HENING MEDICAL INSTRUMENTS CO ., LTD and its Subsidia
• Owner & Operator: HOME AIDE DIAGNOSTICS, INC.
• Contact Address: 1072 S. Powerline Rd. --; Deerfield Bch FL 33442 US
• Official Correspondent:
  • AMGAD - GIRGIS
  • x-800-9150116-x
• US Agent:
  • Amgad Girgis
  • 954 7940221
  • 954 7940631
  • amgad@homeaide.us
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO.6 West Hongdou Road Economic Development Zone ; Huaian Jiangsu, 223005 CN
• Establishment Type:
  • Manufacture Medical Device
  • Foreign Private Label Distributor

• Registration Number: 3005750815
• FEI Number: 3008474962
• Name: HOME AIDE DIAGNOSTICS, INC.
• Owner & Operator: HOME AIDE DIAGNOSTICS, INC.
• Contact Address: 1072 S. Powerline Rd. --; Deerfield Bch FL 33442 US
• Official Correspondent:
  • AMGAD - GIRGIS
  • x-800-9150116-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1072 S Powerline Rd ; Deerfield Bch, FL 33442 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10860006377899 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Universal Knee Brace	2023-11-13
GUDID 10860006377820 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Posture Corrector	2023-11-13
GUDID 10850027494927 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 32g 5/16" 1cc	2023-11-13
GUDID 10850027494910 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 31g 5/16" 1cc	2023-11-13
GUDID 10850027494903 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 31g 5/16" 1/2cc	2023-11-13
GUDID 10850027494897 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 30g 5/16'' 1cc	2023-11-13
GUDID 10850027494880 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 30g 5/16'' 1/2cc	2023-11-13
GUDID 10850027494873 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 30g 1/2" 1cc	2023-11-13
GUDID 10850027494866 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Insulin Syringes 30g 1/2" 1/2cc	2023-11-13
GUDID 10850027494514 HOME AIDE DIAGNOSTICS, INC.	Smart Neb Pediatric Nebulizer	2023-11-13
GUDID 10850027494507 HOME AIDE DIAGNOSTICS, INC.	True Support Neck Brace	2023-11-13
GUDID 10850632007918 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Safety Pen Needles 6MM 31G	2023-05-25
GUDID 10850632007901 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Safety Pen Needles 5MM 31G	2023-05-25
GUDID 10850632007895 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Safety Pen Needles 4MM 32G	2023-05-25
GUDID 10891237001161 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Twist Top Lancets 30G	2022-12-12
GUDID 10891237001178 HOME AIDE DIAGNOSTICS, INC.	Easy Mini Eject Lancing Device 1171	2022-11-29
GUDID 10850027494446 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Pen Needles 4MM 32G	2022-10-10
GUDID 10850027494439 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Pen Needles 5MM 31G	2022-10-10
GUDID 00850027494425 HOME AIDE DIAGNOSTICS, INC.	True Comfort Safety Pen Needles 6MM 31G	2022-10-10
GUDID 10850027494361 HOME AIDE DIAGNOSTICS, INC.	Ultrasonic Mini Nebulizer	2022-09-30
GUDID 10850632007826 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE INSULIN SYRINGE 5/16” | 1/2CC | 30G	2022-08-24
GUDID 10850632007802 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE PEN NEEDLES 4mm | 32G	2022-08-24
GUDID 10850632007796 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE PEN NEEDLES 8mm | 31G	2022-08-24
GUDID 10850632007789 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE PEN NEEDLES 6mm | 31G	2022-08-24
GUDID 10850632007772 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE PEN NEEDLES 5mm | 31G	2022-08-24
GUDID 10850632007765 HOME AIDE DIAGNOSTICS, INC.	ZevRx Twist Top Lancets 30G	2022-08-24
GUDID 10850632007758 HOME AIDE DIAGNOSTICS, INC.	ZevRx Alcohol Pads 100cnt	2022-08-24
GUDID 10850632007741 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE INSULIN SYRINGE 5/16” | 1CC | 30G	2022-08-24
GUDID 10850632007734 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE INSULIN SYRINGE 1/2” | 1/2CC | 30G	2022-08-24
GUDID 10850632007727 HOME AIDE DIAGNOSTICS, INC.	ZevRx STERILE INSULIN SYRINGE 1/2” | 1CC | 30G	2022-08-24
GUDID 10850027494415 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Adult Inhaler Spacer Chamber 4418	2022-08-17
GUDID 00891237001607 HOME AIDE DIAGNOSTICS, INC.	Easy Air Compressor Nebulizer 1607	2022-06-10
GUDID 10891237001598 HOME AIDE DIAGNOSTICS, INC.	True Support Orthopedic Wrist Brace 1591	2021-07-22
GUDID 10891237001963 HOME AIDE DIAGNOSTICS, INC.	BaaySCI Disposable Nasal Swab	2021-06-21
GUDID 10860006377806 HOME AIDE DIAGNOSTICS, INC.	SAPS Health Plus Alcohol Pads	2021-04-06
GUDID 10850632007154 HOME AIDE DIAGNOSTICS, INC.	SAPS Health alcohol pads	2021-04-06
GUDID 10850027494125 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Alcohol Pads	2021-04-06
GUDID 00891237001959 HOME AIDE DIAGNOSTICS, INC.	BaaySCI Alcohol Disinfecting Prep Pads	2021-04-06
GUDID 20850027494177 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 30G 1/2cc 1/2" 1713	2021-04-01
GUDID 10860006377813 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Safety Lancets 30G 50 count	2021-04-01
GUDID 10850632007161 HOME AIDE DIAGNOSTICS, INC.	SAPS Twist Top lancets 30G	2021-04-01
GUDID 10850027494187 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 30G 1cc 1/2" 1720	2021-04-01
GUDID 10850027494163 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 30G 1/2cc 5/16"	2021-04-01
GUDID 10850027494156 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 30G 1cc 5/16"	2021-04-01
GUDID 10850027494149 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 32G 1CC 5/16"	2021-04-01
GUDID 10850027494132 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Twist Top Lancets 30G	2021-04-01
GUDID 10850027494118 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 32G 1/2CC 5/16"	2021-04-01
GUDID 10850027494101 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 31G 1/2CC 5/16"	2021-04-01
GUDID 10850027494095 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Insulin Syringes 31G 1CC 5/16"	2021-04-01
GUDID 10850027494088 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 6MM 31G 1737	2021-04-01
GUDID 10850027494071 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 5MM 31G 1638	2021-04-01
GUDID 10850027494064 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 4MM 32G 1775	2021-04-01
GUDID 10850027494057 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 6MM 33G 7461	2021-04-01
GUDID 10850027494040 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 5MM 33G 7454	2021-04-01
GUDID 10850027494033 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 4MM 33G 7447	2021-04-01
GUDID 10850027494026 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 6MM 32G 7041	2021-04-01
GUDID 10850027494019 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 5MM 32G 7102	2021-04-01
GUDID 10850027494002 HOME AIDE DIAGNOSTICS, INC.	True Comfort Pro Pen Needles 8MM 31G 1706	2021-04-01
GUDID 01089123700171 HOME AIDE DIAGNOSTICS, INC.	SAPS Care Twist Top Lancets 30G	2021-04-01
GUDID 10860003125585 HOME AIDE DIAGNOSTICS, INC.	Nuaskin Skin Tag Remover	2020-12-03
GUDID 00891237001539 HOME AIDE DIAGNOSTICS, INC.	Comfort Shield Adult Underpads	2020-11-06
GUDID 10850632007628 HOME AIDE DIAGNOSTICS, INC.	SAPS LifeStyle Comfort Surgical Stocking (10-20) X-LARGE	2020-10-01
GUDID 10850632007611 HOME AIDE DIAGNOSTICS, INC.	Quick Temp Pro Infrared Thermometer	2020-10-01
GUDID 10891237001949 HOME AIDE DIAGNOSTICS, INC.	SAPS LifeStyle Comfort Surgical Stocking (10-20) LARGE	2020-08-24
GUDID 10891237001932 HOME AIDE DIAGNOSTICS, INC.	SAPS LifeStyle Comfort Surgical Stocking (10-20) MEDIUM	2020-08-24
GUDID 10891237001925 HOME AIDE DIAGNOSTICS, INC.	SAPS LifeStyle Comfort Surgical Stocking (20-30) X-LARGE	2020-08-24
GUDID 10891237001857 HOME AIDE DIAGNOSTICS, INC.	SAPS LifeStyle Comfort Surgical Stocking (20-30) MEDIUM	2020-08-24
GUDID 10850632007604 HOME AIDE DIAGNOSTICS, INC.	SAPS LifeStyle Comfort Surgical Stocking (20-30) LARGE	2020-08-24
GUDID 10850632007598 HOME AIDE DIAGNOSTICS, INC.	Quick Temp Infrared Thermometer	2020-08-10
GUDID 10891237001284 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Alcohol Pads	2020-08-07
GUDID 10850632007581 HOME AIDE DIAGNOSTICS, INC.	Pro Temp Oral Thermometer	2020-05-13
GUDID 10850632007543 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Tempa Check	2020-04-14
GUDID 10850632007550 HOME AIDE DIAGNOSTICS, INC.	Pure Air Mini Nebulizer	2020-04-01
GUDID 10860003125578 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Peak Flow Meter CHILD	2020-03-31
GUDID 10860000526590 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Peak Flow Meter ADULT	2020-03-31
GUDID 10850632007567 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Inhaler Space Chamber w/ INFANT mask 7560	2020-03-31
GUDID 10850632007277 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Inhaler Space Chamber w/ ADULT mask 7270	2020-03-24
GUDID 10850632007536 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Pulse Oximeter	2020-03-23
GUDID 10850632007529 HOME AIDE DIAGNOSTICS, INC.	SHAN Medical Easy Comfort Lancets 30G	2020-03-23
GUDID 10850632007345 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Tempa Check 4-in-1 Infrared thermometer	2020-03-06
GUDID 00850632007492 HOME AIDE DIAGNOSTICS, INC.	Comfort Shield Adult Diapers X-LARGE	2020-03-06
GUDID 00850632007485 HOME AIDE DIAGNOSTICS, INC.	Comfort Shield Adult Diapers LARGE	2020-03-06
GUDID 00850632007478 HOME AIDE DIAGNOSTICS, INC.	Comfort Shield Adult Diapers MEDIUM	2020-03-06
GUDID 10860003125561 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Twist Top Lancets 30G	2020-03-05
GUDID 10860003125547 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Insulin Pen Needles 32G 8mm 50cnt	2020-03-05
GUDID 10860003125530 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Insulin Pen Needles 32G 6mm 50cnt	2020-03-05
GUDID 10860003125523 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Insulin Pen Needles 32G 5mm 50cnt	2020-03-05
GUDID 10860003125516 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Insulin Pen Needles 32G 4mm 50cnt	2020-03-05
GUDID 10860003125509 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Alcohol Pads	2020-03-05
GUDID 10860000526576 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Alcohol Pads 50 count	2020-03-05
GUDID 10860000526583 HOME AIDE DIAGNOSTICS, INC.	SAPS health + Alcohol Pads	2020-02-14
GUDID 10860003125554 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Twist Top Lancets 30G	2020-02-04
GUDID 10850632007383 HOME AIDE DIAGNOSTICS, INC.	Easy Trak II Control Solution High	2020-01-20
GUDID 10850632007376 HOME AIDE DIAGNOSTICS, INC.	Easy Trak II Glucose Test Strips 25 count	2020-01-20
GUDID 10850632007369 HOME AIDE DIAGNOSTICS, INC.	Easy Trak II Blood Glucose Meter	2020-01-20
GUDID 00891237001829 HOME AIDE DIAGNOSTICS, INC.	Talking Sense Upper Arm Blood Pressure Monitor XL cuff 1829	2019-11-08
GUDID 00891237001782 HOME AIDE DIAGNOSTICS, INC.	Talking Sense Upper Arm Blood Pressure Monitor 1782	2019-11-08
GUDID 00891237001744 HOME AIDE DIAGNOSTICS, INC.	Health Sense Upper Arm Blood Pressure Monitor XL cuff 1744	2019-11-08
GUDID 00891237001072 HOME AIDE DIAGNOSTICS, INC.	Heart Check Blood Pressure Monitor DBP-2127	2019-11-08
GUDID 00891237001065 HOME AIDE DIAGNOSTICS, INC.	Health Sense Upper Arm Blood Pressure Monitor 1065	2019-11-08
Co-Balamin Home Aide Diagnostics, Inc., Shandong Yuwang Pharmaceutical Co.,Ltd.	Other Medication	2016-02-05
NDC 69379-038 Home Aide Diagnostics, Inc.	Rotex	2015-08-10
Rotex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-08-10
Veltrix Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Cl. Ltd.	Prescription Medication	2015-07-13
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-11
NDC 69379-013 Home Aide Diagnostics, Inc.	Simanix	2015-07-08
NDC 69379-001 Home Aide Diagnostics, Inc.	Simanix	2015-07-08
Simanix Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Cl. Ltd, Zhejiang Bangli Medical Products Co. Ltd	Prescription Medication	2015-07-08
Simanix Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Cl. Ltd, Zhejiang Bangli Medical Products Co. Ltd	Prescription Medication	2015-07-08
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-07
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-06
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-06
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-03
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-03
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-03
NDC 69379-035 Home Aide Diagnostics, Inc.	Rematex	2015-07-01
NDC 69379-012 Home Aide Diagnostics, Inc.	Rematex	2015-07-01
NDC 69379-004 Home Aide Diagnostics, Inc.	Veltrix	2015-07-01
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-01
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-01
Rematex Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd	Otc Medication	2015-07-01
Silvera Pain Relief Patch Home Aide Diagnostics, Inc.	Otc Medication	2015-05-28
Remaxazon External Patch Home Aide Diagnostics, Inc.	Prescription Medication	2015-03-10
Permavan External Patch Home Aide Diagnostics, Inc.	Prescription Medication	2015-03-10
NDC 69379-285 Home Aide Diagnostics, Inc.	Remaxazon External Patch	2015-03-09
NDC 69379-010 Home Aide Diagnostics, Inc.	Permavan External Patch	2015-03-09
LKB HUAIAN HENING MEDICAL INSTRUMENTS CO ., LTD and its Subsidia [HOME AIDE DIAGNOSTICS, INC.]	Pro Comfort Alcohol prep pads	2015-01-26
Lorenza Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2015-01-16
NDC 69379-014 Home Aide Diagnostics, Inc.	Lorenza Pain Relief Patch	2015-01-01
Velma Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2014-12-02
Silvera Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2014-12-02
Velma Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2014-12-01
Silvera Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2014-12-01
Velma Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2014-11-25
Silvera Pain Relief Patch Home Aide Diagnostics, Inc.	Prescription Medication	2014-11-25
NDC 69379-037 Home Aide Diagnostics, Inc.	Silvera Pain Relief Patch	2014-11-18
NDC 69379-016 Home Aide Diagnostics, Inc.	Velma Pain Relief Patch	2014-11-18
FMK HUAIAN HENING MEDICAL INSTRUMENTS CO ., LTD and its Subsidia [HOME AIDE DIAGNOSTICS, INC.]	Easy Comfort Lancets	2013-10-30

Similar & Related FDA Registered Companies

• Shandong Yuwang Pharmaceutical Co.,Ltd.
• Zhejiang Bangli Medical Products Co. Ltd
• Zhejiang Bangli Medical Products Cl. Ltd.

Related Finance Registrations

NCAGE Code	6MGC4	HOME AIDE DIAGNOSTICS, INC.
CAGE Code	6MGC4	HOME AIDE DIAGNOSTICS, INC.
S.A.M. Registration	6MGC4 [783518983]	HOME AIDE DIAGNOSTICS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009289453	Shanghai ,China (Mainland) -> Miami, Florida	NON WOVEN PADS TWIST TOP LANCETS THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	1607 PCS
2020092211194	Yantian,China (Mainland) -> Miami, Florida	BLACKHEAD REMOVER HS CODE 854370999	38 CTN
202009225471	Singapore,Singapore -> Miami, Florida	EASY AIR NEBULIZER MCN-S600MC EASY NEB PEDIATRIC NEBULIZER MCN-S600MB PURE AIR MINI NEBULIZER MCN-S600A THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	878 PCS
2020091710662	Shanghai ,China (Mainland) -> Miami, Florida	NON WOVEN PADS TWIST TOP LANCETS THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	725 PCS
202009173171	Pusan,South Korea -> Miami, Florida	FOOT SPA MASSAGER THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	475 PCS
202009152446	Pusan,South Korea -> Miami, Florida	ADULT DIAPER	1672 CTN
2020091410712	Ningpo ,China (Mainland) -> Miami, Florida	INSULIN PEN NEEDLE INSULIN PEN NEEDLEINSULIN SYRINGE THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	1720 PCS