FDA Registration
Active
🇹🇼 Taiwan
Penguin ENT Scope model name CP1310F6.CP1313F6
Reg #: 3000279801
·
FEI: 3000279801
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- OPCOM INC.
- Registration Number
- 3000279801
- FEI Number
- 3000279801
- Status
- Active
- Expiry Year
- 2025
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-08-08 |
Proprietary Names
Penguin ENT Scope model name CP1310F6.CP1313F6
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)