FDA Registration
Active
🇹🇼 Taiwan
OPCOM INC.
Reg #: 3000279801
·
FEI: 3000279801
·
Expires 2026
Products
10
Proprietary Names
0
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- OPCOM INC.
- Registration Number
- 3000279801
- FEI Number
- 3000279801
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12F, No.8, Jiankang Rd., Zhonghe Dist.,
- City
- New Taipei City
- Country
- TW
Owner / Operator
- Firm Name
- OPCOM Inc.
- Operator Number
- 10084244
- Address
- 12F, No.8, Jiankang Rd., Zhonghe Dist.,
- City
- New Taipei City
- State
- TW-NWT
- Postal Code
- 23586
- Country
- TW
- Correspondent
- Coco Yao
US Agent
- Business Name
- FullCircle26, Inc.
- Contact Name
- Shelley Mathews
- Address
- 123 South US Hwy 12, Unit #30 Fox Lake
- City
- Fox Lake
- State
- IL
- ZIP
- 60020
- Country
- US
- [email protected]
- Phone
- 224 2802034
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2022-09-19 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2024-05-19 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-11-03 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-01-28 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-08-08 |
| Teeth, Artificial, Backing And Facing | ELK | Class 1 | Dental | No | 2024-05-19 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2022-09-19 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2024-12-19 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2022-12-07 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2022-01-28 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)