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MORTARA INSTRUMENT, INC.

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-667-8272
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 062046149

Catalogue (818)

Page 3 of 17

Device	Model / Reference	Registries	Class	Status
Q-Tel RMS	QTELM-P-AAAA	FDA UDI	Class II	Unknown
CardioSens/Ultra II	047029-00	FDA UDI	Class II	Unknown
Quik-Prep	011440-004	FDA UDI	Class II	Active
Eli 380	ELI380-DBXXX	FDA UDI	Class II	Active
Eli 380	ELI380-ACX4X	FDA UDI	Class II	Active
Patient Cable Lead Set	9293-046-74	FDA UDI	Class II	Active
RScribe	RSCRIBE-6AC-XXBAA	FDA UDI	Class II	Unknown
ELI 150c	BUR150c-W1X	FDA UDI	Class II	Unknown
Surveyor S12	SUR12-MAA-XXXAX	FDA UDI	Class II	Unknown
Eli 380	ELI380-DCS21	FDA UDI	Class II	Active
Scribe	SCRIBEWS-5BA-AAXXX	FDA UDI	Class II	Unknown
HScribe	HSCRIBE-6AA-AAXXA	FDA UDI	Class II	Unknown
Surveyor Central	SCNODE-AAA-EXBEX	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-MEB-ABCAX	FDA UDI	Class II	Unknown
HScribe	V51-1GI	FDA UDI	Class II	Unknown
Surveyor S12	SUR12-QAA-XXXAX	FDA UDI	Class II	Unknown
Surveyor S19	SUR19-PAA-XXAAX	FDA UDI	Class II	Unknown
Surveyor Central	SCSYS-HAE-UBFAX	FDA UDI	Class II	Unknown
Wam	41000-034-50	FDA UDI	Class II	Active
Wam	41000-029-61	FDA UDI	Class II	Unknown
Q-Tel RMS	11089-001-70	FDA UDI	Class II	Active
Surveyor S4	S4-Q-ASX-XXX	FDA UDI	Class II	Unknown
Q-Tel RMS	QTELS-P-AA	FDA UDI	Class II	Unknown
Q-Stress	QS-6ED-AEAAB	FDA UDI	Class II	Active
Eli 380	ELI380-DAX11	FDA UDI	Class II	Active
Eli 380	ELI380-DCX43	FDA UDI	Class II	Active
Snap Adapter	9281-002-50	FDA UDI	Class II	Active
Quik-Prep	031581-00	FDA UDI	Class II	Unknown
Patient Cable	XCLCCMD01A	FDA UDI	Class II	Active
Patient Cable Lead Set	9293-047-67	FDA UDI	Class II	Active
Surveyor S12	SUR12-SAA-XXAAX	FDA UDI	Class II	Active
Surveyor S12	SUR12-RAG-FXABX	FDA UDI	Class II	Active
Trigger Module	30012-024-51	FDA UDI	Class II	Active
Patient Cable	9293-042-50	FDA UDI	Class II	Active
Patient Cable	9293-044-51	FDA UDI	Class II	Active
Eli 380	ELI380-DBX43	FDA UDI	Class II	Active
Eli 380	ELI380-DCX21	FDA UDI	Class II	Active
Surveyor S19	SUR19-AAA-XXAAX	FDA UDI	Class II	Unknown
ELI 150c	ELI150c-GEA-AFHAB	FDA UDI	Class II	Active
Surveyor Central	SCAC-AAA-EXCXX	FDA UDI	Class II	Unknown
XScribe Cardiopulmonary Kit	41000-030-64	FDA UDI	Class II	Active
Surveyor S12	SUR12-NAE-XXXAB	FDA UDI	Class II	Unknown
Wam	41000-038-50	FDA UDI	Class II	Active
ELI 250c	ELI250c-MAA-ABCAX	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-CAA-AAFAD	FDA UDI	Class II	Unknown
Am15e	9293-063-50	EUDAMEDFDA UDI	Class II	Active
Quick-Trace Multi-purpose ECG electrodes	000310-001	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-CAA-ADAAX	FDA UDI	Class II	Unknown
Eli 280	ELI280-AAA-AAFBT	FDA UDI	Class II	Active
ELI 150c	ELI150c-GAA-ABCBB	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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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