# OrbusNeich Medical (Shenzhen) Co., Ltd. (manufacturer, SHENZHEN Guangdong, CN): 2 new FDA device listings, incl. catheter, percutaneous, cutting/scoring

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Owner / operator | Orbusneich Medical Co. Ltd (Hong Kong) |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | SHENZHEN Guangdong, CN |
| New listings | 2 |
| Devices | Catheter, Percutaneous, Cutting/Scoring; Catheter, Percutaneous |
| Product codes | PNO, DQY |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | JADE SCORE PTA Scoring Balloon Dilatation Catheter; Teleport Glide Microcatheter |
| First new listing | 2026-06-04 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 3003775186 |
| 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.