A non-sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy, following wound healing, to provide the patient with voice restoration. It is placed by the trained patient into the fistula. It has a
| Company | Devices | Share |
|---|---|---|
| Freudenberg Medical, Llc | 43 | 78% |
| Atos Medical Ab | 12 | 22% |
Company = labeler of record on GUDID. 2 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) | 55 |
Use these as the dimensions to specify in a tender line.
55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheoesophageal speech valve, non-indwelling", from 2 companies. The largest labeler is Freudenberg Medical, Llc with 78% of records.
EWL (Prosthesis, Laryngeal (Taub))
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.