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 10860006377882 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Safety Pen Needles 31G 6mm	2024-10-16
GUDID 10860006377875 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Safety Pen Needles 31G 5mm	2024-10-16
GUDID 10860006377868 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Safety Pen Needles 32G 4mm	2024-10-16
GUDID 10860006377837 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Breath Exerciser	2024-10-16
GUDID 10860000526569 HOME AIDE DIAGNOSTICS, INC.	True Comfort Insulin Syringes 31G 1CC 5/16" 1881	2024-10-16
GUDID 10860000526552 HOME AIDE DIAGNOSTICS, INC.	True Comfort Insulin Syringes 31G 1/2CC 5/16" 1881	2024-10-16
GUDID 10860000526545 HOME AIDE DIAGNOSTICS, INC.	True Comfort Insulin Pen Needles 31G 5mm	2024-10-16
GUDID 10860000526538 HOME AIDE DIAGNOSTICS, INC.	True Comfort Insulin Pen Needles 31G 6mm	2024-10-16
GUDID 10860000526521 HOME AIDE DIAGNOSTICS, INC.	True Comfort Insulin Pen Needles 32G 4mm	2024-10-16
GUDID 10860000526514 HOME AIDE DIAGNOSTICS, INC.	True Comfort Alcohol Pads	2024-10-16
GUDID 10860000526507 HOME AIDE DIAGNOSTICS, INC.	True Comfort Twist Top Lancets 30G	2024-10-16
GUDID 10850632007987 HOME AIDE DIAGNOSTICS, INC.	True Comfort Quad Cane	2024-10-16
GUDID 10850632007963 HOME AIDE DIAGNOSTICS, INC.	True Comfort Folding Walker-in-Stroller with seat	2024-10-16
GUDID 10850632007956 HOME AIDE DIAGNOSTICS, INC.	True Comfort Folding Walker with wheels	2024-10-16
GUDID 10850632007949 HOME AIDE DIAGNOSTICS, INC.	True Comfort Folding Walker	2024-10-16
GUDID 10850632007932 HOME AIDE DIAGNOSTICS, INC.	True Health Sense Blood Pressure Monitor 1065	2024-10-16
GUDID 10850632007925 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Prostate Patch	2024-10-16
GUDID 10850632007260 HOME AIDE DIAGNOSTICS, INC.	Pro Health Mini: Talking Blood Pressure Monitor	2024-10-16
GUDID 10850058864027 HOME AIDE DIAGNOSTICS, INC.	True-Comfort Safety Pen Needles 6MM 31G	2024-10-16
GUDID 10850058864010 HOME AIDE DIAGNOSTICS, INC.	True-Comfort Safety Pen Needles 5MM 31G	2024-10-16
GUDID 10850058864003 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count	2024-10-16
GUDID 10850027494989 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count	2024-10-16
GUDID 10850027494972 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count	2024-10-16
GUDID 10850027494668 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Syringes 31G 1/2" 0.3CC	2024-10-16
GUDID 10850027494651 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort Syringes 31G 5/16" 0.3CC	2024-10-16
GUDID 10850027494590 HOME AIDE DIAGNOSTICS, INC.	True Comfort Shoulder Compression Wrap	2024-10-16
GUDID 10850027494545 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Safety Lancets 30G 100cnt	2024-10-16
GUDID 10850027494538 HOME AIDE DIAGNOSTICS, INC.	Total Comfort Knee Support Sleeve	2024-10-16
GUDID 10850027494521 HOME AIDE DIAGNOSTICS, INC.	Total Comfort Elbow Support Sleeve LG	2024-10-16
GUDID 10850027494491 HOME AIDE DIAGNOSTICS, INC.	Ultra Comfort Heated Socks	2024-10-16
GUDID 10850027494484 HOME AIDE DIAGNOSTICS, INC.	Ultra Comfort Heating Patch	2024-10-16
GUDID 10850027494477 HOME AIDE DIAGNOSTICS, INC.	Pro Comfort Lumbar Support	2024-10-16
GUDID 10850027494453 HOME AIDE DIAGNOSTICS, INC.	Pro Health Track: Bluetooth Blood Pressure Monitor	2024-10-16
GUDID 10850027494354 HOME AIDE DIAGNOSTICS, INC.	Pure Comfort Leg Massager	2024-10-16
GUDID 10850027494347 HOME AIDE DIAGNOSTICS, INC.	True Comfort Knee Compression Wrap	2024-10-16
GUDID 01085027494383 HOME AIDE DIAGNOSTICS, INC.	Ultra Comfort Body Massager	2024-10-16
GUDID 00850632007171 HOME AIDE DIAGNOSTICS, INC.	Foot Comfort Ankle Gauntlet	2024-10-16
GUDID 00850058864006 HOME AIDE DIAGNOSTICS, INC.	True-Comfort Safety Pen Needles 4MM 32G	2024-10-16
GUDID 10850058864102 HOME AIDE DIAGNOSTICS, INC.	True-Comfort Pen Needles 4mm 1775	2024-07-05
GUDID 10850632007888 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort 0.2L Sharps Container {0.21 Quarts}	2024-06-24
GUDID 10850058864096 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort 5L Sharps Container {5.28 Quarts}	2024-06-24
GUDID 10850058864089 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort 3L Sharps Container {3.17 Quarts}	2024-06-24
GUDID 10850027494613 HOME AIDE DIAGNOSTICS, INC.	Easy Comfort 1L Sharps Container {1.06 Quarts}	2024-06-24
GUDID 10850027494330 HOME AIDE DIAGNOSTICS, INC.	True Comfort Back Compression Wrap	2024-06-24
GUDID 10850027494316 HOME AIDE DIAGNOSTICS, INC.	Easy Talk/PlusII Control Solution HIGH	2024-06-24
GUDID 10850027494309 HOME AIDE DIAGNOSTICS, INC.	Easy Talk/PlusII Control Solution LOW	2024-06-24
GUDID 10850027494224 HOME AIDE DIAGNOSTICS, INC.	Easy Talk/Plus II Glucose Test Strips	2024-06-24
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 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
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