FDA Registration
Active
🇹🇼 Taiwan
MonoStereo
Reg #: 3030142846
·
FEI: 3030142846
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDICALTEK CO. LTD
- Registration Number
- 3030142846
- FEI Number
- 3030142846
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4F, No. 26, Keya Rd., Daya Dist.
- City
- Taichung
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K234096
Owner / Operator
- Firm Name
- MedicalTek Co. Ltd
- Operator Number
- 10092169
- Address
- 4F, No. 26, Keya Rd., Daya Dist.
- City
- Taichung
- State
- TW-TXG
- Postal Code
- 428
- Country
- TW
- Correspondent
- Shen L Ching Yeh
US Agent
- Business Name
- Medes USA C/O Matan Arazy
- Contact Name
- Benny Arazy
- Address
- 15201 6th Ave NE, ,
- City
- Shoreline
- State
- WA
- ZIP
- 98155
- Country
- US
- [email protected]
- Phone
- 415 9921126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2024-12-11 |
Proprietary Names
MonoStereo
Establishment Types
Manufacture Medical Device