# Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti (foreign exporter, Maltepe Istanbul, TR): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti |
| Owner / operator | Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Maltepe Istanbul, TR |
| New listings | 10 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories; Catheter, Percutaneous; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Drills, Burrs, Trephines & Accessories (Simple, Powered); Motor, Drill, Electric; Motor, Drill, Pneumatic; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment |
| Product codes | GEI, DQY, ERL, HBE, HBC, HBB, HSZ |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Cardiovascular, Ear, Nose, Throat, Neurology |
| Brand names | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES; Percutaneous Catheter; CATHETER, PERCUTANEOUS; Catheter, percutaneous; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| First new listing | 2026-08-05 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 3015453963 |
| 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: 2026-11-04T21:52:36.524Z.
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.