# Orantech Inc. (foreign exporter, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Orantech Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 3 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories; Staple, Removable (Skin); Oximeter |
| Product codes | GEI, GDT, DQA |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Cardiovascular |
| Brand names | Electrosurgical Pads; Disposable skin staplers; Fingertip Pulse Oximeter |
| First new listing | 2026-06-18 |
| Latest new listing | 2026-08-10 |
| FDA registration number | 3013783488 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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: 2026-10-28T20:51:27.468Z.
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.