Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680411

FEI Number

3008205331

Entity Name

HOSPITAL EQUIPMENT MFG. CO.

City/State/Country

NOIDA Uttar Pradesh, IN

Establishment Address

A19/20 SECTOR 7,, NOIDA Uttar Pradesh 201301, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HOSPITAL EQUIPMENT MFG. CO. (Owner Number: 9008836)

Owner / Operator Contact Address

D-313 SECTOR 63, --, NOIDA, U.P., IN-NOTA 201301, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AIR CUSHION RUBBER INVALID RING hospital equipment mfg. co. HEMC HEMC MI medical Mask all sizes HEMC HEMC HEMC HEMC HE-FLON, HEMC HEMC HEMC PINARD TYPE HEMC HEMC HEMC HEMC HEMC JACQUES Hospital Equipment Mfg. Co. HEMC HEMC HEMC HEMC GUEDAL AIRWAY MI Medical Ambus HEMC HEMC HEMC HEMC HEMC HEMC Face Mask MANUAL BLOOD CELL COUNTING DEVICE HEMC HEMC HEMC HEMC MACKINTOSH SHEETING DOUCHE APPARATUS HEMC HEMC HEMC HEMC, HE HEMC HEMC MI Medical 4 compartment tray HEMC HEMC DOLPHIN SUTURE NEEDLE PLUNGERLESS SYRINGE HEMC MI Medical Malaysia 4 compartment tray HEMC HEMC HEMC HEMC hemc hemc HEMC HEMC THERMOMETER HEMC HEMC HEMC HEMC STETHOSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	1994-05-12
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2014-08-27
FOB	Bedpan	General Hospital	Class 1	880.6730	2008-05-30
HWB	Extractor	Orthopedic	Class 1	888.4540	2021-12-03
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2021-06-03
FNW	Pad, Kelly	General, Plastic Surgery	Class 2	878.4370	2021-06-02
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2023-04-10
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2024-10-30
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2007-10-24
HWA	Impactor	Orthopedic	Class 1	888.4540	2021-12-03
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-08-23
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2021-09-07
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2004-06-02
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2021-06-03
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-12-03
IWO	Apron, Protective	Radiology	Class 1	892.6500	2024-07-29
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2021-12-03
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2022-02-26
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-09-11
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2021-06-03
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2017-09-02
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2014-08-28
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2009-03-07
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-09-08
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2009-03-07
JBS	Timer, General Laboratory	Clinical Chemistry	Class 1	862.2050	2024-03-23
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-06-03
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2021-06-03
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2008-10-22
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2021-09-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2008-10-16
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2021-06-23
FJW	Ring, Joint	Gastroenterology, Urology	Class 1	876.5540	2022-05-09
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-01-17
GHO	Hemocytometer	Hematology	Class 1	864.6160	2005-12-12
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2022-05-09
HXN	Applier, Cerclage	Orthopedic	Class 1	888.4540	2021-12-03
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2008-11-10
EYX	Drape, Pure Latex Sheet, With Self-Retaining Finger Cot	General, Plastic Surgery	Class 2	878.4370	2018-09-08
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2005-12-12
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2022-05-25
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-12-03
HXC	Wrench	Orthopedic	Class 1	888.4540	2022-05-09
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2025-08-23
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2022-05-09
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2018-09-08
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-11-10
HAS	Needle, Neurosurgical Suture	Neurology	Class 1	882.4650	2021-06-07
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1997-08-19
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2018-11-01
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2021-12-03
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2021-06-03
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2005-12-12
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2012-09-28
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2024-03-22
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2025-01-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-09-08
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2025-01-16
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2022-05-09
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2019-02-08
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2022-05-25
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2004-05-11
HXW	Bender	Orthopedic	Class 1	888.4540	2021-12-03
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2019-02-08

Official Correspondent

SACHDEVA KUMAR

US Agent Details

Wen Wang Email: wen.wang@willowglenfda.com Phone: (619) 8690249

Related Public Records

Same Entity

HOSPITAL EQUIPMENT MFG. CO.

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
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680411. Last updated year: 2026. Please use registration number 9680411 when referencing this establishment in official correspondence.