Cofoe - ZBC24
2026-02-24
COFOE MEDICAL TECHNOLOGY CO.,LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016426850 | 3016426850 | COFOE MEDICAL TECHNOLOGY CO.,LTD | 1 | N | 2026-01-01 | No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 C Changsha Hunan CN 410000 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 236176 | 1822867638 | K230277 | Pulse Oximeter(Model OHT60,OXH78) | DQA | 2024-01-04 |
| 236176 | 1525305578 | ||||
| 236176 | 1003506994 | ||||
| 236176 | 1022295571 | ||||
| 236176 | 1116828625 | ||||
| 236176 | 1158638629 | ||||
| 236176 | 1171458804 | ||||
| 236176 | 1198979681 | ||||
| 236176 | 1279564915 | ||||
| 236176 | 1366241266 | ||||
| 236176 | 1382451691 | ||||
| 236176 | 1415576559 | ||||
| 236176 | 1460390860 | ||||
| 236176 | 1549077198 | ||||
| 236176 | 1586699134 | ||||
| 236176 | 1633315274 | ||||
| 236176 | 1695545124 | ||||
| 236176 | 1733383507 | ||||
| 236176 | 1756222238 | ||||
| 236176 | 1815437543 | ||||
| 236176 | 1882845443 | ||||
| 236176 | 1923597453 | ||||
| 236176 | 1943191589 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQA | 1 | 2024-01-04 |
GUDID#
COFOE - Behind-the-ear hearing aid, single ear (ABS, wired charging, hearing aid size: 8.85mm*53.66mm*14.95mm)
2022-01-10
COFOE - Back of ear hearing aid, single ear, (ABS, hearing aid size: 8.85mm*53.66mm*14.95mm)
2022-01-10
COFOE - Behind-the-ear hearing aid, single ear (ABS, wired charging, hearing aid size: 10.83mm*45.57mm)
2022-01-10
COFOE - Behind-the-ear hearing aid, single ear (ABS, wireless charging, charging case size: 76*60*32 (mm) Hearing aid size: 45*36*11(mm)
2022-01-10
COFOE - In-ear hearing aid, binaural (ABS, contact charging, charging case size: 85.5*33.5*33.5 (mm) Hearing aid size: 24*17*24 (mm)
2022-01-10
COFOE - In-ear hearing aid, binaural (ABS, contact charging, charging box size: 85.5*33.5*33.5 (mm) Hearing aid size: 20*14*24 (mm)
2022-01-10
COFOE - In-ear hearing aid, binaural (ABS, contact charging, charging case size: 85.5*33.5*33.5 (mm) Hearing aid size: 24*17*24 (mm)
2022-01-10
COFOE - In-ear hearing aid, binaural (ABS, contact charging, charging box size: 85.5*33.5*33.5 (mm) Hearing aid size: 20*14*24 (mm)
2022-01-10
COFOE - Behind-the-ear hearing aid, single ear (ABS, wired charging, hearing aid size: 10.83mm*45.57mm)
2022-01-10
COFOE - In-ear hearing aid, single ear (ABS, battery replacement, hearing aid size: 16*12*20 (mm)
2022-01-10
COFOE - Behind-the-ear hearing aid, single ear (ABS, battery replacement (hearing aid size: 12.84mm*9.8mm*38.73mm)
2022-01-10
COFOE - In-ear hearing aid, single ear (ABS, battery replacement, hearing aid size: 16*12*20 (mm)
2022-01-10
COFOE - Behind-the-ear hearing aid, single ear (ABS, wired charging, hearing aid size :10.83mm*45.57mm)
2022-01-10
COFOE - Hearing aid size: 16*10*30 (excluding earplug wire)
2022-01-10
COFOE - In-ear hearing aid, double ear (ABS, contact charging, charging box size: 62*50*24.5 (mm) Hearing aid size: 16*12*21 (mm)
2022-01-10
Cofoe - Wrist Brace
2024-07-04
Cofoe - Wrist Brace
2024-07-04
Cofoe - Wrist Brace
2024-07-04
Cofoe - Wrist Brace
2024-07-04
Cofoe - Wrist Brace
2024-07-04
cofoe - Ostomy Barrier Strips
2025-02-18
Cofoe - KF-29
2024-02-01
cofoe - Lumbar support
2024-12-13
cofoe - One-piece Drainable IIeostomy Bag
2024-12-09
babaka - Back Brace
2024-12-09
cofoe - Cane/Crutch
2024-12-09
cofoe - One-piece Drainable IIeostomy Bag
2024-12-09
cofoe - One-piece Drainable IIeostomy Bag
2024-12-09
cofoe - Two-piece Drainable IIeostomy Bag
2024-12-09
cofoe - Skin Barrier Wipe
2024-12-09
cofoe - Adhesive Remover
2024-12-09
cofoe - Ostomy Belt
2024-12-09
cofoe - Ostomy Barrier Ring
2024-12-09
cofoe - Ostomy Barrier Ring
2024-12-09
cofoe - Ostomy Barrier Strip
2024-12-09
cofoe - Ostomy Barrier Strip
2024-12-09
MOVFRI - Air Mattress
2024-11-28
babaka - Back Brace
2024-10-09
babaka - Back Brace
2024-10-09