# Taiwan Main Orthopaedic Biotechnology Co., Ltd (manufacturer, Taichung City, TW): 2 new FDA device listings, incl. device, digital image storage, radiological

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Taiwan Main Orthopaedic Biotechnology Co., Ltd |
| Owner / operator | Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Taichung City, TW |
| New listings | 2 |
| Devices | Device, Digital Image Storage, Radiological; System, Image Processing, Radiological |
| Product codes | LMB, LLZ |
| Device classes | Class I, Class II |
| Medical specialties | Radiology |
| Brand names | Asclepius AI Table (TBK-AI-84 Ultra, TBK-AI-65 Vision 4K); OOOPDS |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-10-21 |
| FDA registration number | 3014232530 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.
