An external device intended to replace the female breast typically after a mastectomy. It is made of various materials to simulate the appearance and texture of a breast and is typically fitted into a brassiere.
| Company | Devices | Share |
|---|---|---|
| Trulife Limited | 814 | 74% |
| Amoena Medizin-Orthopädie-Technik Gmbh | 215 | 20% |
| Natural Breast K.K. | 36 | 3% |
| American Breast Care, L.P. | 31 | 3% |
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 |
|---|---|---|
| NOJ | PROSTHESIS, BREAST, EXTERNAL, NO ADHESIVE | 814 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 282 |
Use these as the dimensions to specify in a tender line.
1,096 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External breast prosthesis", from 4 companies. The largest labeler is Trulife Limited with 74% of records.
NOJ (PROSTHESIS, BREAST, EXTERNAL, NO ADHESIVE), KCZ (Prosthesis, Breast, External, Used With Adhesive)
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.
Add external breast prosthesis to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
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.