Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMORTARA INSTRUMENT, INC.
US
Last updated May 24, 2026
What MORTARA INSTRUMENT, INC. makes
Mortara Instrument, Inc. manufactures professional multichannel electrocardiographs, reusable electrocardiographic lead sets, and cardiac stress exercise monitoring systems. Their portfolio also includes long-term ambulatory ECG recording analyser software, multi-patient physiologic monitoring systems for intensive and general healthcare, and cardiology information system applications. Additional offerings include ambulatory ECG recorders and patient health record information systems, along with associated cardiopulmonary monitoring kits and lead sets.
All listed devices fall under Class II regulatory classification in the U.S. and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mortara.com
- —
- —
- [email protected]
- Phone
- 888-667-8272
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 062046149
Catalogue (818)
Page 16 of 17| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Patient Cable | 9293-017-51 | FDA UDI | Class II | Active |
| Patient Cable Lead Set | 9293-041-50 | FDA UDI | Class II | Active |
| Patient Cable | 9293-032-53 | FDA UDI | Class II | Active |
| Patient Cable Lead Set | 9293-043-50 | FDA UDI | Class II | Active |
| ELI 250c | ELI250c-MDB-ABCAX | FDA UDI | Class II | Unknown |
| Q-Tel RMS | QTELM-P-ABXA | FDA UDI | Class II | Unknown |
| Q-Stress Patient Cable | 60-00184-01 | EUDAMEDFDA UDI | Class II | Active |
| Patient Cable | 012-0844-01 | FDA UDI | Class II | Active |
| Surveyor S12 | SUR12-PAC-XXAAX | FDA UDI | Class II | Unknown |
| ELI 250c | ELI250c-CAA-AAFBX | FDA UDI | Class II | Unknown |
| Modality Manager | MDLTYMGR-5AC-BXXXX | FDA UDI | Class II | Unknown |
| ELI 150c | ELI150c-GAA-AFGAB | FDA UDI | Class II | Active |
| Modality Manager | MODALITYMGR-5AD-AXXXB | FDA UDI | Class II | Active |
| Pyramis | 11095-002-61 | FDA UDI | Class II | Active |
| Wam | 41000-031-51 | EUDAMEDFDA UDI | Class II | Active |
| Am12 | 41000-032-53 | EUDAMEDFDA UDI | Class II | Active |
| Wam | 41000-036-51 | EUDAMEDFDA UDI | Class II | Active |
| Mortara Surveyor Patient Monitor | K161517 | FDA 510(k) | Class II | Active |
| Eli 230 Electrocardiograph | K100127 | FDA 510(k) | Class II | Active |
| Model Eli 100 Electrocardiograph | K920627 | FDA 510(k) | N/A | Active |
| H3+ Holter Recorder | K152626 | FDA 510(k) | Class II | Active |
| Eli 280 Electrocardiograph | K122073 | FDA 510(k) | Class II | Active |
| Surveyor S2 | K182297 | FDA 510(k) | Class II | Active |
| T12s Telemetry Transmitter | K081800 | FDA 510(k) | Class II | Active |
| Eli 200+ Audicor | K031182 | FDA 510(k) | Class II | Active |
| Model Eli-100/St Electrocardiograph | K895232 | FDA 510(k) | N/A | Active |
| Mortara Monitoring Waveform Viewer | K141811 | FDA 510(k) | Class II | Active |
| Surveyor Central Station | K131929 | FDA 510(k) | Class II | Active |
| Burdick Division (e-500) | K861850 | FDA 510(k) | Class II | Active |
| Mortara Instrument #101 | K832050 | FDA 510(k) | Class II | Active |
| Mortara Instrument Model Eli-Xr (treadmill Included) | K880664 | FDA 510(k) | Class II | Active |
| H-Scribe | K004017 | FDA 510(k) | Class II | Active |
| Holter Recorder H3+ | K043010 | FDA 510(k) | Class II | Active |
| Mortara Instrument Model X-Scribe (treadmill Included) | K900720 | FDA 510(k) | Class II | Active |
| Mortara Instrument Model Ecg Prevu | K920377 | FDA 510(k) | N/A | Active |
| Eli Pc Electrocardiograph | K093339 | FDA 510(k) | Class II | Active |
| Model El-1 W/St Monitor Option (acronym = Eli/Stm) | K864580 | FDA 510(k) | Class II | Active |
| Surveyor S4 Mobile Monitor | K160685 | FDA 510(k) | Class II | Active |
| X-Scribe Ii | K022618 | FDA 510(k) | Class II | Active |
| Eli 10 Electrocardiograph Model Eli 10 | K102206 | FDA 510(k) | Class II | Active |
| Mortara Instrument St Central Station | K922927 | FDA 510(k) | Class II | Active |
| Model Eli 200 Electrocardiograph | K920626 | FDA 510(k) | N/A | Active |
| Mortara Eli 10 Electrocardiograph | K070539 | FDA 510(k) | Class II | Active |
| Model Eli 300 Electrocardiograph | K933143 | FDA 510(k) | N/A | Active |
| Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | K152944 | FDA 510(k) | Class II | Active |
| Eli 350 Electrocardiograph | K062677 | FDA 510(k) | Class II | Active |
| Mortara Surveyor Telemetry Central Station | K060135 | FDA 510(k) | Class II | Active |
| Mortara Instrument, Inc. E-Scribe | K930558 | FDA 510(k) | Class II | Active |
| Mortara Surveyor Patient Monitor | K123556 | FDA 510(k) | Class II | Active |
| Mortara Eli 350 Electrocardiograph | K082946 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Mortara Instrument, Inc. has two recall records initiated between October 7, 2014, and May 29, 2015, both of which are marked as terminated. The first involved the ELI 380 electrocardiograph, where a potential issue was identified regarding incorrect patient demographic associations during waveform transmission in a specific workflow. The second concerned the Surveyor and S12/S19 Patient Monitors, citing a potential safety hazard related to improper mounting using the provided 75mm VESA hole pattern in the battery cover.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 29, 2015 | Z-1796-2015 | — | terminated | Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system. |
| Oct 7, 2014 | Z-0110-2015 | — | terminated | Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p |