An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragme
| Company | Devices | Share |
|---|---|---|
| Dornier Medtech America, Inc. | 72 | 84% |
| Dornier Medtech Gmbh | 7 | 8% |
| Typenex Medical Llc | 5 | 6% |
| Rhein Laser Technologies Co.,Ltd. | 2 | 2% |
Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 101 |
| GEX | Powered laser surgical instrument | 3 |
Use these as the dimensions to specify in a tender line.
86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laser lithotripsy system", from 4 companies. The largest labeler is Dornier Medtech America, Inc. with 84% of records.
GEX (Powered Laser Surgical Instrument), GEX (Powered laser surgical instrument)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.