An artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to move only as a result of the direct application of external forces.
| Company | Devices | Share |
|---|---|---|
| Hugh Steeper Limited | 56 | 53% |
| Macu4 Gmbh | 50 | 47% |
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 |
|---|---|---|
| IRA | Hand, External Limb Component, Mechanical | 56 |
| ISS | Prosthesis, Thigh Socket, External Component | 30 |
| ISZ | Unit, Wrist, External Limb Component, Mechanical | 20 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Passive hand prosthesis", from 2 companies. The largest labeler is Hugh Steeper Limited with 53% of records.
IRA (Hand, External Limb Component, Mechanical), ISS (Prosthesis, Thigh Socket, External Component), ISZ (Unit, Wrist, External Limb Component, Mechanical)
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.