FDA Registration
Active
🇹🇼 Taiwan
Taiwan Main Orthopaedic Biotechnology Co., Ltd
Reg #: 3014232530
·
FEI: 3014232530
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Taiwan Main Orthopaedic Biotechnology Co., Ltd
- Registration Number
- 3014232530
- FEI Number
- 3014232530
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F., No.41, Keya Rd. Daya Dist.
- City
- Taichung City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K220554
Owner / Operator
- Firm Name
- Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- Operator Number
- 10058896
- Address
- 2F., No.41, Keya Rd., Daya Dist.
- City
- Taichung
- State
- TW-TXG
- Postal Code
- 428015
- Country
- TW
- Correspondent
- Jacky Fan
US Agent
- Business Name
- SURGLASSES LLC
- Contact Name
- Nina Wang
- Address
- 10373 Trademark St., Suite K, Rancho Cucamonga, CA 91730
- City
- Rancho Cucamonga
- State
- CA
- ZIP
- 91730
- Country
- US
- [email protected]
- Phone
- 888 8367198
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2023-01-05 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2026-05-12 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2018-11-07 |
| Device, Storage, Images, Ophthalmic | NFF | Class 1 | Radiology | No | 2021-01-04 |
Proprietary Names
Caduceus S
Asclepius AI Table (TBK-AI-84 Ultra, TBK-AI-65 Vision 4K)
Foresee-X
Asclepius Radiology (TBK 99EA, TBK 99, TBK 84, TBK 84EA, TBK 65 4K, TBK 43LT)
Establishment Types
Manufacture Medical Device