An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried
| Company | Devices | Share |
|---|---|---|
| Spacelabs Healthcare (Washington), Inc | 13 | 23% |
| Northeast Monitoring, Inc. | 12 | 21% |
| Norav Medical Ltd. | 8 | 14% |
| Microport Crm Srl | 7 | 12% |
| Midmark Corporation | 6 | 11% |
| Labtech Kereskedelmi És Mérnöki Szolgáltató Korlátolt FelelőSségű Társaság | 4 | 7% |
| Atsens Co., Ltd. | 4 | 7% |
| Memtec Corporation | 1 | 2% |
| Fourth Frontier Technologies Private Limited | 1 | 2% |
| Nasiff Associates Inc | 1 | 2% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 33 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 20 |
| DQK | Computer, diagnostic, programmable | 13 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 12 |
| DXH | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | 5 |
| DQK | Computer, Diagnostic, Programmable | 5 |
Use these as the dimensions to specify in a tender line.
57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic long-term ambulatory recording analyser", from 10 companies. The largest labeler is Spacelabs Healthcare (Washington), Inc with 23% of records.
DQK (COMPUTER, DIAGNOSTIC, PROGRAMMABLE), MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), DQK (Computer, diagnostic, programmable), MWJ (Electrocardiograph, Ambulatory (Without Analysis))
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.