A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and cl
| Company | Devices | Share |
|---|---|---|
| Respironics, Inc. | 41 | 79% |
| Wallac Oy | 5 | 10% |
| Vela Operations Singapore Pte. Ltd. | 3 | 6% |
| Sysmex Corporation | 1 | 2% |
| Horiba Abx Sas | 1 | 2% |
| Polymer Technology Systems, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| OUG | Medical device data system | 47 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 6 |
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE | 5 |
| PFF | High Throughput Dna Sequence Analyzer | 3 |
| OUG | Medical Device Data System | 2 |
| MNT | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY | 2 |
Use these as the dimensions to specify in a tender line.
52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Clinical laboratory information system", from 6 companies. The largest labeler is Respironics, Inc. with 79% of records.
OUG (Medical device data system), JQP (Calculator/Data Processing Module, For Clinical Use), CBK (VENTILATOR, CONTINUOUS, FACILITY USE), PFF (High Throughput Dna Sequence Analyzer)
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.