FDA Registration
Active
🇹🇼 Taiwan
MEDIMAGING INTEGRATED SOLUTION INC.
Reg #: 3015316279
·
FEI: 3015316279
·
Expires 2026
Products
21
Proprietary Names
2
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- MEDIMAGING INTEGRATED SOLUTION INC.
- Registration Number
- 3015316279
- FEI Number
- 3015316279
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F, No.24-2, Industry E. Rd. IV,, Hsinchu Science Park
- City
- Hsinchu Hsinchu (City)
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K234113
Owner / Operator
- Firm Name
- Medimaging Integrated Solution Inc.
- Operator Number
- 10037829
- Address
- 3F, No.24-2, Industry E. Rd. IV, Hsinchu Science Park
- City
- Hsinchu
- State
- Hsinchu (City)
- Postal Code
- 30077
- Country
- TW
- Correspondent
- Luu Hsu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reminder, Medication | NXQ | Class 1 | Physical Medicine | No | 2023-10-30 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2022-06-28 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2016-11-29 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2014-11-01 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-08-12 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2012-02-08 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2012-10-11 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-03-18 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2023-11-20 |
| Device, Communications, Images, Ophthalmic | NFG | Class 1 | Radiology | No | 2021-05-28 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2012-02-08 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2011-08-23 |
| Camera, Still, Surgical | FTT | Class 1 | General, Plastic Surgery | No | 2012-07-31 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2011-08-23 |
| Tape, Camera, Surgical | FXN | Class 1 | General, Plastic Surgery | No | 2021-03-14 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2022-07-03 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2023-10-18 |
| Speculum, Illuminated | FXF | Class 1 | General, Plastic Surgery | No | 2012-02-08 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2015-09-09 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2020-01-14 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2017-05-24 |
Proprietary Names
Ophthalmic eye shield
MPD 100: MiiS Wound Care System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)