FDA Registration
Active
🇹🇼 Taiwan
Acute Ideas Co., Ltd.
Reg #: 3005031124
·
FEI: 3005031124
·
Expires 2026
Products
13
Proprietary Names
0
Establishment Types
5
Classifications
13
Registration Details
- Registration Name
- Acute Ideas Co., Ltd.
- Registration Number
- 3005031124
- FEI Number
- 3005031124
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F, No.11, Lane 35, Jihu Road,
- City
- Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K200712
Owner / Operator
- Firm Name
- Acute Ideas Co., Ltd.
- Operator Number
- 10023653
- Address
- 3F, No.11, Lane 35, Jihu Road,
- City
- Taipei
- State
- TW-TPE
- Postal Code
- 114
- Country
- TW
- Correspondent
- Albert Chen
US Agent
- Business Name
- A Cute Baby, Inc.
- Contact Name
- Jessica Wang
- Address
- 865 N 1430 W
- City
- Orem
- State
- UT
- ZIP
- 84057
- Country
- US
- [email protected]
- Phone
- 801 6098168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2025-07-23 |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | Class 1 | Obstetrics/Gynecology | No | 2024-11-25 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2020-05-10 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2009-06-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2025-12-03 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-11 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2015-10-26 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-07-23 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2011-11-16 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2011-11-16 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2026-03-29 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2009-08-04 |
| Nursing Pad, Cohesive Gel | NXH | Class 1 | General Hospital | No | 2026-03-29 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)