FDA Registration
Active
🇨🇳 China
COFOE MEDICAL TECHNOLOGY CO.,LTD
Reg #: 3016426850
·
FEI: 3016426850
·
Expires 2026
Products
22
Proprietary Names
44
Establishment Types
4
Classifications
22
Registration Details
- Registration Name
- COFOE MEDICAL TECHNOLOGY CO.,LTD
- Registration Number
- 3016426850
- FEI Number
- 3016426850
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 Changsha, Hunan, CHINA
- City
- Changsha Hunan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230277
Owner / Operator
- Firm Name
- COFOE MEDICAL TECHNOLOGY CO.,LTD
- Operator Number
- 10061943
- Address
- No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 Changsha, Hunan, CHINA
- City
- Changsha
- State
- Hunan
- Postal Code
- 410000
- Country
- CN
- Correspondent
- Xueqin Huang
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 509 5816099
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2024-06-17 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2021-05-10 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2024-11-25 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2021-05-10 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2021-11-19 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2024-07-25 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2024-07-02 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-02-12 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-03-16 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2024-06-17 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2024-11-15 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2024-11-25 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2022-07-28 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2022-07-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-01-09 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 2024-11-25 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2021-05-21 |
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 2024-11-25 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-07-28 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2022-07-28 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2026-02-13 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2021-11-19 |
Proprietary Names
Back support strap
Back Brace
Posture Corrector
Walker
Ostomy tie strip
Skin Barrier Wipe
Ostomy Belt
Cane
Adult Diapers (Garment, Protective, For Incontinence)
Pull up pants
Medical Nursing Pads
CERVICAL FIXATOR
Neck Brace
Knee Strap
Knee Brace
Wrist Brace
Ankle Brace
Elbow Brace
Infrared Thermometer
TDP lamp
lumbar fixation belt
lumbar support
Lumbar Support belt
Anti-decubitus Mattress
Air Mattress with Compressor
Air Mattress
Mattress
Alternating Pressure Pump & Bubble Mattress
Adhesive Remover
Adhesive stripper rub
oxygen regulator
Suction machine(stationary aspirator)
Pulse Oximeter(Model OHT 60XH78)
Ostomy drainage bag
Bathing chair
Skin Barrier Powder
Barrier Ring
Barrier Strip
Ostomy bag filter
Ostomy Paste/Skin Barrier Paste
Band Aid
Compression stockings
Hearing aid, air conduction
Colostomy Bag (Pouch,Colostomy)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)