FDA Registration
Active
🇨🇳 China
Dongguan City Ruimi Gift Products Co Ltd
Reg #: 3015745029
·
FEI: 3015745029
·
Expires 2026
Products
62
Proprietary Names
66
Establishment Types
3
Classifications
62
Registration Details
- Registration Name
- Dongguan City Ruimi Gift Products Co Ltd
- Registration Number
- 3015745029
- FEI Number
- 3015745029
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Suite1815 Unit2 of Build 3 No.200 Hongfu Rd Nancheng Dis
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171961
Owner / Operator
- Firm Name
- Dongguan City Ruimi Gift Products Co Ltd
- Operator Number
- 10060982
- Address
- Suite1815 Unit2 of Build 3 No.200 Hongfu Rd Nancheng Dis
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523000
- Country
- CN
- Correspondent
- Yuhua Xu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2019-07-24 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2019-07-24 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2019-07-24 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2019-07-24 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2019-07-24 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2019-07-24 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2019-07-24 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2019-07-24 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2019-07-24 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2023-01-11 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Papers, Ion | DMG | Class 1 | Clinical Chemistry | No | 2019-07-24 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2019-07-24 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2019-07-24 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-07-24 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2019-07-24 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2023-01-11 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2019-07-24 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2019-07-24 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2019-07-24 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2019-07-24 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2019-07-24 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2019-07-24 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2019-07-24 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2019-07-24 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2019-07-24 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2019-07-24 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2019-07-24 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2019-07-24 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2019-07-24 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2019-07-24 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Reminder, Medication | NXQ | Class 1 | Physical Medicine | No | 2019-07-24 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | Class 1 | Obstetrics/Gynecology | No | 2019-07-24 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2019-07-24 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-07-24 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2019-07-24 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2019-07-24 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2019-07-24 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2024-12-31 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-05-07 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2019-07-24 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2023-01-11 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2019-07-24 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2019-07-24 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2019-07-24 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2019-07-24 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2019-07-24 |
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
Medical waste bag
Oropharyngeal Airway
Vinyl patient examination glove
FACE MASK
BURN DRESSING, BURN GEL, BURN RELIVE
Suture Training Kit
Stretcher
Colostomy Bag
Transparent wound dressing, Wound dressing, Chest Seal
Brush
Cotton; Cotton ball; Cotton roll; Zig-zag cotton roll
SPLINT, HARD AND COMPONENTS
Crank flashlight, multifucntion torch
Safety Pin, Pins, Assorted Pins
Raincoat
Eye pad
Garment Incontinence Blanket, Emergency Blanket
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device