Cofoe Medical Technology Co., Ltd.
Manufacturer and brand owner in Changsha, Hunan, China. 22 device types, 19 products catalogued, 1 clearance.
Cofoe Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Crutch, Oximeter and 20 other device types. 19 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
22device types registered with the FDA
19products catalogued under its own name
1510(k) clearance
Registration
| Registered name | COFOE MEDICAL TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016426850 |
| FEI number | 3016426850 |
| DUNS | 544425204 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 可孚医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91430111696240992G |
| Source | NMPA UDI database |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 Changsha, Hunan, CHINA |
| Postal code | 410000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Bathing chair | 2021 | 193 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | Suction machine(stationary aspirator) | 2022 | 30 |
| Cement, Stomal Appliance, Ostomy | Class 1 | Ostomy bag filter, Skin Barrier Powder, Barrier Strip, Ostomy Paste/Skin Barrier Paste, Barrier Ring | 2024 | 7 |
| Clinical Electronic Thermometer | Class 2 | Infrared Thermometer | 2026 | 49 |
| Crutch | Class 1 | Cane | 2021 | 112 |
| Dressing, Wound, Hydrophilic | Class 1 | Band Aid | 2022 | 195 |
| Garment, Protective, For Incontinence | Class 1 | Pull up pants, Adult Diapers (Garment, Protective, For Incontinence), Medical Nursing Pads | 2021 | 181 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Hearing aid, air conduction | 2026 | 57 |
| Irrigator, Ostomy | Class 2 | Ostomy drainage bag | 2024 | 2 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | TDP lamp | 2023 | 235 |
| Mattress, Air Flotation, Alternating Pressure | Class 2 | Air Mattress with Compressor, Mattress, Anti-decubitus Mattress, Alternating Pressure Pump & Bubble Mattress, Air Mattress | 2024 | 52 |
| Orthosis, Cervical | Class 1 | Cervical Fixator, Neck Brace | 2024 | 114 |
| Orthosis, Lumbar | Class 1 | Lumbar Support belt, lumbar fixation belt, lumbar support | 2024 | 110 |
| Orthosis, Thoracic | Class 1 | Back support strap, Posture Corrector, Back Brace | 2024 | 30 |
| Oximeter | Class 2 | Pulse Oximeter(Model OHT 60XH78) | 2024 | 70 |
| Pouch, Colostomy | Class 1 | Colostomy Bag (Pouch,Colostomy) | 2021 | 25 |
| Protector, Ostomy | Class 1 | Ostomy tie strip, Ostomy Belt, Skin Barrier Wipe | 2024 | 33 |
| Regulator, Pressure, Gas Cylinder | Class 1 | oxygen regulator | 2022 | 27 |
| Solvent, Adhesive Tape | Class 1 | Adhesive Remover, Adhesive stripper rub | 2024 | 20 |
| Splint, Hand, And Components | Class 1 | Knee Strap, Wrist Brace, Elbow Brace, Ankle Brace, Knee Brace | 2024 | 144 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | Class 2 | Compression stockings | 2022 | 21 |
| Walker, Mechanical | Class 1 | Walker | 2021 | 183 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Cofoe | QUF | 16 |
| Cofoe | ILH | 11 |
| cofoecare | DWL | 10 |
| cofoe | IPT | 9 |
| Cofoe | DWL | 9 |
| babaka | IPT | 7 |
| cofoe | IQE | 7 |
| Cofoe | ITJ | 7 |
| cofoe | EZR | 5 |
| cofoe | EZQ | 4 |
| Cofoe | IQK | 3 |
| cofoe | EXE | 2 |
| Cofoe | DQA | 2 |
| Cofoe | ILS | 2 |
| babaka | IQE | 1 |
| cofoe | IPR | 1 |
| cofoe | KOX | 1 |
| Cofoe | ILY | 1 |
| Movfri | FNM | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230277 | 2024-01-04 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 5,000 |
| Main products | Blood pressure monitors, Blood glucose meters, Cardiac monitors, Electric wheelchairs, Intelligent care beds |
| Certifications | National High-Tech Enterprise, National Intellectual Property Advantage Enterprise, National Industrial Design Center |
| Export markets | 60+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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