Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015745029

FEI Number

3015745029

Entity Name

Dongguan City Ruimi Gift Products Co Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Suite1815 Unit2 of Build 3 No.200 Hongfu Rd Nancheng Dis, Dongguan Guangdong 523000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Dongguan City Ruimi Gift Products Co Ltd (Owner Number: 10060982)

Owner / Operator Contact Address

Suite1815 Unit2 of Build 3 No.200 Hongfu Rd Nancheng Dis, Dongguan, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SYRINGE, IRRIGATING (NON DENTAL) Facial tissues Moleskin, blister pad Gauze pad; Gauze sponge, STERILE AND NON-STERILE DRESSING; STERILE AND NON-STERILE PADS, Kaolin Hemostatic Gauze Tourniquet, Nonpneumatic Depressor, Tongue, Non-Surgical Elastic Bandage, Gauze Eye washing solution; Skin washing solution Abdominal band, waist belt Paracord Bracelet, Warning Vest, Reflective Jacket Tweezers Anesthetic Gas Mask Anti choking device Elastomer SILICONE TISSUE, PAPER TISSUE, paper facial tissue, toilet tissue Blood collection Cervical collar, cervical gear, collar support, neck collar, neck splint, neck brace Adhesive Tape; Band-Aid, Adhesive Bandage, SLING ARM, triangular gauze bandage, Gauze Bandage; Adhesive Bandage 1; Adhesive Bandage 3/4; Adhesive Fingertip Fabric Bandage; Adhesive Knuckle Fabric Bandage, Moleskin Blister Protectant Adhesive Spot Bandage 7/8; Adhesive Tape Silk 2.5 Cm X 5 Yds.; Butterfly Wound Closures; Elbow/Knee Adhesive Bandage, Conforming Elastic Bandages, First Aid Tape Roll 1/2; Junior Adhesive Bandage 3/8x1.5; CPR MASK Splint, finger splint Decompression Needle Joint, knee, external brace, knee immobilizer Garment Protective For Incotinence, Diaper, Disposable Baby Diaper, Lovy Baby SAFETY PINS CPR Shield; Mask, Oxygen Radiographic protective glove ARM sling, hand support , shoulder support Inhaler, NASAL, VAPOR INHALER Anti-inflammatory gel, Anti-inflammatory cream, Disinfectant gel, Disinfectant cream; Disinfectant, BZK PAD, Alcohol Pad, Sting Relief, Medical Devices Sanitizer Spray, Antiseptic Towelette; water purification COTTON TIPPED/ABSORBENT TIPPED CPR Mask Single-use Cleaning Brushes, ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE, emergency whistle Bag, Urine Collection, Leg, For External Use, Non-Sterile Stethoscope Razor surgical disposable razor First Aid Kit With Drug COLD PACK, HOT OR COLD PAD, insant cold pad Emergency light stick Surgical scrub brush Reminder pill box Multifunctional knife, knift, scissors Pads, menstrual, scented-deodorized Water bottle First Aid Kit Without Drug ARM sling, hand support , shoulder support Medical waste bag Oropharyngeal Airway Vinyl patient examination glove FACE MASK BURN DRESSING, BURN GEL, BURN RELIVE Suture Training Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2019-07-24
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-07-24
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2019-07-24
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-07-24
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2019-07-24
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2019-07-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-07-24
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2019-07-24
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-07-24
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2019-07-24
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-07-24
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2019-07-24
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-01-11
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2019-07-24
DMG	Papers, Ion	Clinical Chemistry	Class 1	862.2230	2019-07-24
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2019-07-24
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2019-07-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-07-24
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2019-07-24
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2019-07-24
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-01-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-07-24
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2019-07-24
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2019-07-24
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2019-07-24
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2019-07-24
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2019-07-24
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2019-07-24
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2019-07-24
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2019-07-24
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-07-24
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-07-24
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2019-07-24
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2019-07-24
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-07-24
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2019-07-24
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2019-07-24
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-07-24
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2019-07-24
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2019-07-24
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2019-07-24
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2019-07-24
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2019-07-24
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2019-07-24
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2019-07-24
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2019-07-24
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2019-07-24
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2019-07-24
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2019-07-24
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-07-24
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-12-31

Official Correspondent

Yuhua Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Dongguan City Ruimi Gift Products 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
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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

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2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015745029. Last updated year: 2026. Please use registration number 3015745029 when referencing this establishment in official correspondence.