A prefabricated cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) ready to be assem
| Company | Devices | Share |
|---|---|---|
| Hugh Steeper Limited | 96 | 73% |
| Trulife Limited | 36 | 27% |
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 |
|---|---|---|
| IPM | Cover, Limb | 96 |
| ISH | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT | 36 |
Use these as the dimensions to specify in a tender line.
132 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External limb prosthesis finishing component, non-customized", from 2 companies. The largest labeler is Hugh Steeper Limited with 73% of records.
IPM (Cover, Limb), ISH (COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT)
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.