FDA Registration
Active
🇨🇳 China
AID UNITED INTERNATIONAL CO., LIMITED
Reg #: 3005951403
·
FEI: 3005951403
·
Expires 2026
Products
65
Proprietary Names
37
Establishment Types
4
Classifications
65
Registration Details
- Registration Name
- AID UNITED INTERNATIONAL CO., LIMITED
- Registration Number
- 3005951403
- FEI Number
- 3005951403
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROOM 505,T2, NO. 168, TAIHONG ROAD
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K160802
Owner / Operator
- Firm Name
- AID UNITED INTERNATIONAL CO., LIMITED
- Operator Number
- 9090586
- Address
- ROOM 520, NO. 1065, WUZHONG ROAD
- City
- SHANGHAI
- State
- CN-SH
- Postal Code
- 201103
- Country
- CN
- Correspondent
- HANSON - WANG
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 |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2022-10-18 |
| Reminder, Medication | NXQ | Class 1 | Physical Medicine | No | 2022-10-18 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2020-10-11 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2010-12-25 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2010-12-25 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2021-10-18 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2020-10-11 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2022-10-18 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2007-12-10 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2006-08-03 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2010-12-25 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2010-12-25 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-05 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-11-20 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2021-10-18 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2021-10-15 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2010-12-25 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2024-11-20 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2022-10-18 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2022-10-18 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2007-12-10 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2018-11-26 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2021-10-18 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2010-12-25 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2023-06-08 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2024-11-20 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2010-12-25 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2010-12-25 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2020-10-11 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2010-12-25 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2024-11-20 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2021-10-18 |
| Orthosis, Truncal, For Dysmenorrhea | NJB | Class 1 | Physical Medicine | No | 2021-10-18 |
| Floss, Dental | JES | Class 1 | Dental | No | 2009-12-04 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2024-11-20 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2020-10-11 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2021-07-14 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2020-10-11 |
| Toothbrush, Ionic, Battery-Powered | MMD | Class 1 | Dental | No | 2024-11-20 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2010-12-25 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2010-12-25 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2006-08-03 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2021-10-18 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2021-07-14 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2018-11-26 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2010-12-25 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2021-10-18 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2018-11-26 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2010-12-25 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 2022-10-18 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2014-12-03 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2021-10-18 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2020-04-05 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2010-12-25 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2014-12-03 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2014-12-03 |
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2022-10-18 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2020-10-11 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2010-12-25 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-06-08 |
Proprietary Names
SUPPORT, ARM
Reminder, medication
water bottle
REUSABLE HOT COLD PACK
EYE PADS
BINDER, ABDOMINAL
HYDROGEL dressing
DURA-AID DRESSING
MULTIPLE ADHESIVE BANDAGE
SUPPORTS
Dispenser
INSOLES
STOCKING, ELASTIC
BAND OR BELT, PELVIC SUPPORT
ice pack
SUPPORT
TOOTHBRUSH, MANUAL
DURA-AID
cast bandage
FORCEPS
gauze pad
ORTHOSIS, LUMBAR SUPPORT
DENTAL FLOSS
TOE SPACER
scissor
splints
MULTIPLE BANDAGE
ORTHOSIS, CERVICAL-THORACIC, RIGID
FIRST AID KIT
HOT COLD PACK
HAND, EXTERNAL LIMB COMPONENT, POWERED
Hydrocolloid Dressing
penlight
JOINT, ELBOW, EXTERNAL LIMB COMPONENT,
scissors
DISPENSER, LIQUID MEDICATION
One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility