Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043646

FEI Number

1043646

Entity Name

Medegen Medical Products

City/State/Country

GALLAWAY, TN, US

Establishment Address

209 MEDEGEN DR., GALLAWAY, TN 38036, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medegen Medical Products (Owner Number: 9005738)

Owner / Operator Contact Address

209 MEDEGEN DR., --, Gallaway, TN 38036, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Plastic Clamp Gent-L-Kare Vaginal Irrigation Set Enema Buckets & Kits SITZ BATH MANUAL Sharps Container Towel Wash Cloth Drape Pillow Case Sheet URINAL Calculi Strainer Specimen Containers Specialty Bags Specimen Pan ClickSeal Containers Gown, Isolation Underarm Pads Tips Snap Cap Clik Seal Medicine Cup Tumbler MEDICINE CUP Cane Crutch Multitrans Emesis Bags OR Basin Ring Basin Wash Basins Bowls EMESIS BASIN Eye Shields Cap Shoe Covers Starswab Sampling Swab Syringe - various- Irrigation and Suction BOWL STAND IV Spill Kit Culture Tubes Petri Dish Urinary Leg Bag Urinary Drainage Bag INSTRUMENT TRAYS BEDPAN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2011-12-14
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2012-02-10
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2011-03-09
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2001-08-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-02-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-06-17
FNP	Urinal	General Hospital	Class 1	880.6730	2001-08-31
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2001-08-31
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2010-01-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-06-05
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2014-06-17
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2001-08-31
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2010-01-21
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2001-08-31
IPS	Cane	Physical Medicine	Class 1	890.3075	2014-06-17
IPR	Crutch	Physical Medicine	Class 1	890.3150	2014-06-17
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2020-06-10
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2001-08-31
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2011-07-15
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2014-06-17
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2014-06-17
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2020-06-10
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-06-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2011-05-18
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2001-08-31
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2013-02-04
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2010-02-11
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2011-05-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-08-31
FOB	Bedpan	General Hospital	Class 1	880.6730	2001-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medegen Medical Products

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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
3002834291	MIAN SHAHID CORP.	MUZAFFAR PUR, SIALKOT Punjab, PK
3009750712	Quiroproductos de Cuauhtemoc S. De R.L. de C.V.	Cuauhtemoc Chihuahua, MX
1820334	Cook Incorporated	Bloomington, IN, US
3006859759	XIAN KAYDEE MEDICAL APPLIANCES CO., LTD.	xian Shaanxi, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043646. Last updated year: 2026. Please use registration number 1043646 when referencing this establishment in official correspondence.