# Platinum Focus Group Ltd. (foreign exporter, London London, City of, GB): 16 new FDA device listings, incl. catheter, urological

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Platinum Focus Group Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | London London, City of, GB |
| New listings | 16 |
| Devices | Catheter, Urological; Catheter, Retention Type, Balloon; Non-Coring (Huber) Needle; Orthosis, Lumbo-Sacral; Collector, Ostomy; Adaptor, Ureteral Catheter; Introducer, Catheter; Bandage, Cast; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Syringe, Piston |
| Product codes | KOD, EZL, PTI, IPY, EXB, EYI, DYB, ITG, HWE, FMF, EXF, MON, FGE, CCK, BYG |
| Device classes | Class I, Class II |
| Medical specialties | Gastroenterology, Urology, General Hospital, Physical Medicine, Cardiovascular, General, Plastic Surgery, Anesthesiology |
| Brand names | injectable infusion set; ORTHOSIS, LUMBO-SACRAL; Collector, ostomy; ADAPTOR, URETERAL CATHETER; Introducer, catheter; BANDAGE, CAST; NSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT; 510(k) |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3030446844 |
| 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.