A device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a doub
| Company | Devices | Share |
|---|---|---|
| Atos Medical Ab | 71 | 89% |
| Freudenberg Medical, Llc | 8 | 10% |
| Covidien Lp | 1 | 1% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | 115 |
| EPE | Brush, Cleaning, Tracheal Tube | 4 |
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 1 |
Use these as the dimensions to specify in a tender line.
80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheoesophageal speech valve, indwelling", from 3 companies. The largest labeler is Atos Medical Ab with 89% of records.
EWL (Prosthesis, Laryngeal (Taub)), EPE (Brush, Cleaning, Tracheal Tube), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES)
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.