HOSPITAL & HOMECARE IMP. & EXP. CO., LTD

FDA Device Registration & Listing · NANJING Jiangsu, CN · Registration 3006897996

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006897996
FEI Number
3006897996
Entity Name
HOSPITAL & HOMECARE IMP. & EXP. CO., LTD
City/State/Country
NANJING Jiangsu, CN
Establishment Address
Room 608-611,No.5 Zhongtai International Plaza,, NO.311 MIDDLE OF JIANGDONG ROAD,CENTRAL BUSINESS DISTRICT, NANJING Jiangsu 210002, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Hospital & Homecare Imp. & Exp. Co., Ltd (Owner Number: 10024296)
Owner / Operator Contact Address
Rm 608-611,No. 5 Zhongtai Intl Plaza, No. 311 Middle of Jiangdong Road, Nanjing City, CN-JS 210019, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

REGULATOR, VACUUM APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Bandage, liquid, skin protectant URINAL SCISSORS, MEDICAL, DISPOSABLE Sterilizer, tonometer THERMOMETER, CLINICAL MERCURY Electrode, electrocardiograph FORCEPS CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE STETHOSCOPE HEAD COVER, SHOE, OPERATING-ROOM Dressing, wound, hydrophilic SPECULA ACCESSORIES CONTAINER, SPECIMEN, NON-STERILE TABLE, OPERATING-ROOM, ELECTRICAL NEEDLE, GASTRO-UROLOGY PAD, EYE PUMP, NEBULIZER, ELECTRICALLY POWERED Speculum, vaginal, nonmetal SYRINGE, ENT FORCEPS, DRESSING, DENTAL INSOLES, MEDICAL CAP, SURGICAL CANNULA, NASAL, OXYGEN TREADMILL, POWERED PACK, HEAT, MOIST ATTACHMENT, COMMODE, WHEELCHAIR Dressing, wound, hydrogel without drug and/or biologic Synchronizer, ECG / respirator, radiographic STYLET, SURGICAL, GENERAL & PLASTIC SURGERY CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, NON-STERILE MASK, OXYGEN, NON-REBREATHING COVERSLIPS, MICROSCOPE SLIDE Spatula, ophthalmic Applicator, absorbent tipped, sterile BED, MANUAL FILM, CAMERA, SURGICAL SPECIMEN/TISSUE, IDENTIFICATION ORIENTATION STRETCHER, HAND-CARRIED BANDAGE, CAST ARMREST, WHEELCHAIR SCISSORS, GENERAL, SURGICAL BLADE, SCALPEL TAPE, ORTHOPEDIC STRIPPER, SURGICAL DEPRESSOR, METAL TONGUE, SURGICAL MASSAGER, THERAPEUTIC, MANUAL TUBING, PRESSURE AND ACCESSORIES NEEDLE, CERCLAGE, GYNECOLOGICAL ADAPTOR, HOLDER, SYRINGE BANDAGE, ELASTIC SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY KNIFE, NASAL NEEDLE, CATHETER BAG, ICE OTOSCOPE BEDDING, DISPOSABLE, MEDICAL CONTAINER, SPECIMEN, URINE, DRUGS OF ABUSE, OVER THE COUNTER NEEDLE, SUTURING, DISPOSABLE Curtain, protective, radiographic EQUIPMENT, PHOTOGRAPHIC, FOR PHYSIOLOGIC FUNCTION MONITOR Component, cast CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE MICROSCOPE, PHASE CONTRAST SOLVENT, ADHESIVE TAPE STETHOSCOPE, ESOPHAGEAL NEEDLE, BIOPSY, CARDIOVASCULAR COTTON, ROLL TROCAR, LARYNGEAL PIPETTE, PASTEUR APPLICATOR, ABSORBENT TIPPED, NON-STERILE BATH, INCUBATORS/WATER, ALL Elastomer, silicone, for scar management NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE BAG, INTESTINE TABLE, OPERATING-ROOM, MECHANICAL DEVICE, FIXATION, TRACHEAL TUBE Radiographic protective Glove SHOE, CAST AIRWAY, NASOPHARYNGEAL BED, HYDRAULIC, ADJUSTABLE HOSPITAL Knife, ophthalmic Gown, examination HOLDER, URETERAL CATHETER BAG, URINE COLLECTING, URETEROSTOMY SYRINGE, IRRIGATING (NON DENTAL) MASK, GAS, ANESTHETIC BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL THERMOMETER, CLINICAL COLOR CHANGE BAG, URINARY, ILEOSTOMY ADAPTOR, HOLDER, SYRINGE NEEDLE, DENTAL Discs, strips and reagents, microorganism differentiation APPLICATOR, VAGINAL TABLE, OPERATING-ROOM, MANUAL RAZOR, SURGICAL SURGICAL TABLE CUSHION Dressing, wound, occlusive COVER, MATTRESS (MEDICAL PURPOSES) Specula, ophthalmic BED, AC-POWERED ADJUSTABLE HOSPITAL Kit, first aid, talking TIMER, APGAR SCALE, PATIENT KNIFE, TONSIL DEPRESSOR, TONGUE, NON-SURGICAL SCALPEL, ONE-PIECE Circuit, breathing (w connector, adaptor, y piece) SLIDES, MICROSCOPE SCALE, SPONGE, SURGICAL, ELECTRICALLY-POWERED MASK, OXYGEN SCALE, SURGICAL SPONGE POUCH, COLOSTOMY SHOE AND SHOE COVER, CONDUCTIVE CATHETER, INFUSION MASK, SCAVENGING PACK, HOT OR COLD, DISPOSABLE GARMENT, PROTECTIVE, FOR INCONTINENCE sponge,nonresorbable for external use NEEDLE, CERCLAGE, GYNECOLOGICAL STETHOSCOPE, MANUAL BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE FORCEPS, GENERAL & PLASTIC SURGERY STRIPPER, VEIN, DISPOSABLE NEEDLE, NEUROSURGICAL SUTURE FOOTREST, WHEELCHAIR Dressing, compression Clamp, umbilical TRAP, STERILE SPECIMEN Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) PRESS, VEIN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDP Regulator, Vacuum General Hospital Class 2 880.6740 2014-12-22
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2018-03-02
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2008-07-08
FNP Urinal General Hospital Class 1 880.6730 2014-12-16
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 2008-07-08
HKZ Sterilizer, Tonometer Ophthalmic Class 1 886.1940 2014-12-25
FLK Thermometer, Clinical Mercury General Hospital Class 2 880.2920 2008-07-09
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2014-12-23
HTD Forceps General, Plastic Surgery Class 1 878.4800 2008-07-08
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2010-12-02
BZS Stethoscope Head Anesthesiology Class 1 868.1930 2014-12-25
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2008-07-09
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2008-07-08
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2008-07-08
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2010-12-02
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2014-12-25
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2008-07-08
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2008-07-08
JPW Pump, Nebulizer, Electrically Powered Ear, Nose, Throat Class 1 874.5220 2014-12-23
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2014-12-23
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2008-07-08
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2014-12-23
KYS Insoles, Medical General Hospital Class 1 880.6280 2008-07-09
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2014-12-22
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2014-12-23
IOL Treadmill, Powered Physical Medicine Class 1 890.5380 2014-12-25
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2008-07-08
INB Attachment, Commode, Wheelchair Physical Medicine Class 1 890.3920 2014-12-25
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2008-07-08
IXO Synchronizer, Ecg / Respirator, Radiographic Radiology Class 1 892.1970 2014-12-23
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-12-23
NNL Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile Pathology Class 1 864.3250 2010-12-02
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2018-03-02
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2008-07-08
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2008-07-08
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2008-07-08
FNJ Bed, Manual General Hospital Class 1 880.5120 2020-12-31
FXT Film, Camera, Surgical General, Plastic Surgery Class 1 878.4160 2014-12-22
MJI Specimen/Tissue, Identification Orientation Pathology Class 1 864.3010 2010-12-02
FPP Stretcher, Hand-Carried General Hospital Class 1 880.6900 2014-12-25
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2008-07-08
IML Armrest, Wheelchair Physical Medicine Class 1 890.3920 2014-12-25
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2008-07-08
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2008-01-17
HXT Tape, Orthopedic General, Plastic Surgery Class 1 878.4800 2008-07-08
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2008-07-09
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2014-12-23
LYG Massager, Therapeutic, Manual Physical Medicine Class 1 890.5660 2014-12-25
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2018-03-02
HDH Needle, Cerclage, Gynecological Obstetrics/Gynecology Class 1 884.4530 2008-07-08
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2014-12-22
FQM Bandage, Elastic General Hospital Class 1 880.5075 2008-07-08
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-07-08
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2008-07-08
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2008-07-08
KYR Bag, Ice General Hospital Class 1 880.6050 2008-07-08
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2008-07-09
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2008-07-08
MPQ Container, Specimen, Urine, Drugs Of Abuse, Over The Counter Pathology Class 1 864.3260 2010-12-02
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2008-07-08
IWQ Curtain, Protective, Radiographic Radiology Class 1 892.6500 2008-07-08
EXZ Equipment, Photographic, For Physiologic Function Monitor Gastroenterology, Urology Class 1 876.1500 2014-12-23
LGF Component, Cast Orthopedic Class 1 888.5940 2008-07-09
KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Pathology Class 1 864.3250 2010-12-02
IBM Microscope, Phase Contrast Pathology Class 1 864.3600 2008-07-08
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2008-07-08
BZW Stethoscope, Esophageal Anesthesiology Class 1 868.1910 2014-12-25
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2008-07-08
EFN Cotton, Roll Dental Class 1 872.6050 2014-12-23
KAB Trocar, Laryngeal Ear, Nose, Throat Class 1 874.4420 2014-12-23
GJW Pipette, Pasteur Hematology Class 1 864.6160 2008-01-17
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2008-07-08
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2014-12-23
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2014-12-23
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2008-07-08
KGY Bag, Intestine General, Plastic Surgery Class 1 878.4100 2008-07-08
FWX Table, Operating-Room, Mechanical General, Plastic Surgery Class 1 878.4950 2014-12-25
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2019-12-26
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2008-07-08
IPG Shoe, Cast Physical Medicine Class 1 890.3025 2008-07-09
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2014-12-22
FNK Bed, Hydraulic, Adjustable Hospital General Hospital Class 1 880.5110 2014-12-25
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2008-07-08
FME Gown, Examination General Hospital Class 1 880.6265 2008-07-08
EYJ Holder, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2014-12-23
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 2008-07-08
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2008-07-09
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2014-12-23
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2008-07-09
FQZ Thermometer, Clinical Color Change General Hospital Class 1 880.2900 2008-07-09
EXH Bag, Urinary, Ileostomy Gastroenterology, Urology Class 1 876.5900 2008-07-08
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2014-12-22
DZM Needle, Dental Dental Class 1 872.4730 2014-12-23
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2014-12-22
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2008-07-09
FSE Table, Operating-Room, Manual General, Plastic Surgery Class 1 878.4950 2014-12-25
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2008-07-08
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2008-07-08
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2014-12-22
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2008-07-09
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2008-07-08
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2014-12-25
OVR Kit, First Aid, Talking General, Plastic Surgery Class 1 878.4014 2014-12-23
LHB Timer, Apgar General Hospital Class 1 880.2930 2014-12-25
FRW Scale, Patient General Hospital Class 1 880.2720 2014-12-25
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 2008-07-08
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2008-07-09
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2008-07-08
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2014-12-23
KEW Slides, Microscope Pathology Class 1 864.3010 2008-01-17
MRL Scale, Sponge, Surgical, Electrically-Powered General Hospital Class 1 880.2740 2008-07-08
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2014-12-23
FQA Scale, Surgical Sponge General Hospital Class 1 880.2740 2008-07-08
EZQ Pouch, Colostomy Gastroenterology, Urology Class 1 876.5900 2014-12-23
BWP Shoe And Shoe Cover, Conductive General, Plastic Surgery Class 1 878.4040 2008-07-09
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2014-12-22
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2008-07-09
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2008-07-08
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2019-12-26
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2008-07-08
HDH Needle, Cerclage, Gynecological Obstetrics/Gynecology Class 1 884.4530 2008-07-08
EPE Brush, Cleaning, Tracheal Tube Anesthesiology Class 1 868.5795 2014-12-23
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2014-12-25
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2008-07-08
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-07-08
GAJ Stripper, Vein, Disposable General, Plastic Surgery Class 1 878.4800 2008-07-09
HAS Needle, Neurosurgical Suture Neurology Class 1 882.4650 2008-07-08
IMM Footrest, Wheelchair Physical Medicine Class 1 890.3920 2014-12-25
MHW Dressing, Compression General Hospital Class 1 880.5075 2008-07-09
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2014-12-23
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2010-12-02
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2008-07-08
JYW Press, Vein Ear, Nose, Throat Class 1 874.4420 2014-12-23

Official Correspondent

Aline Wang

US Agent Details

Ameet Desai Email: ameet.desai@halstedhealth.com Phone: (858) 5396246

Related Public Records

Same Entity

Hospital & Homecare Imp. & Exp. Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08
K913967 Doxtech, Inc. DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM 1991-10-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006897996. Last updated year: 2026. Please use registration number 3006897996 when referencing this establishment in official correspondence.
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