# Rhenus Se & Co. Kg (foreign exporter, Holzwickede North Rhine-Westphalia, DE): 11 new FDA device listings, incl. introducer, catheter

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Rhenus Se & Co. Kg |
| Owner / operator | Rhenus SE & Co. KG |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Holzwickede North Rhine-Westphalia, DE |
| New listings | 11 |
| Devices | Introducer, Catheter; Dilator, Vessel, For Percutaneous Catheterization; Stent, Iliac; Coronary Drug-Eluting Stent; Coronary Covered Stent; Stent, Superficial Femoral Artery; Catheter, Angioplasty, Peripheral, Transluminal; Catheter, Percutaneous; Stent, Coronary; Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Product codes | DYB, DRE, NIO, NIQ, NIV, NIP, LIT, DQY, MAF, LOX |
| Device classes | Class II, Class III, f |
| Medical specialties | Cardiovascular |
| Brand names | FORTRESS; ASTRON; ORSIRO MISSION; PAPYRUS; Pulsar-18 T3; Passeo-35 HP; PRO-Kinetic Energy; Passeo-18 |
| First new listing | 2026-05-05 |
| Latest new listing | 2026-05-05 |
| FDA registration number | 3014656749 |
| 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.