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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 5 of 17

Device	Model / Reference	Registries	Class	Status
HScribe	HSCRIBE-6AC-AXXXC	FDA UDI	Class II	Active
ELI 250c	ELI250c-MAA-AABAX	FDA UDI	Class II	Unknown
Modality Manager	MDLTYMGR-5AE-AXXXB	FDA UDI	Class II	Unknown
ELI 25c	BUR250c-C1X	FDA UDI	Class II	Unknown
Q-Stress	QS6-MLTC1	FDA UDI	Class II	Active
Surveyor Central	SCNODE-AAA-BJBEX	FDA UDI	Class II	Unknown
Eli 280	ELI280-AAA-AAFAD	FDA UDI	Class II	Active
HScribe	HSCRIBE-6AA-AAXXE	FDA UDI	Class II	Unknown
Surveyor Central	SCNODE-DAA-BXXFX	FDA UDI	Class II	Unknown
Eli 380	ELI380-ACX3X	FDA UDI	Class II	Active
CardioConfirm	11111-001-50	FDA UDI	Class II	Active
Surveyor S12	SUR12-MAC-XXAAX	FDA UDI	Class II	Unknown
H12+	H12PLUS-BHB-XXXXX	FDA UDI	Class II	Unknown
Patient Cable	9293-033-53	EUDAMEDFDA UDI	Class II	Active
ELI 250c	ELI250c-CAA-AACBX	FDA UDI	Class II	Unknown
ELI 150c	ELI150c-BEA-ACGBD	FDA UDI	Class II	Active
ELI 150c	ELI150c-CAA-AAGBX	FDA UDI	Class II	Active
Patient Cable	9293-033-52	EUDAMEDFDA UDI	Class II	Active
HScribe	HSCRIBE-5AC-AXXXA	FDA UDI	Class II	Unknown
Eli 380	ELI380-ACS11	FDA UDI	Class II	Active
Eli 380	ELI380-ACX11	FDA UDI	Class II	Active
Surveyor Central	SCSYS-IAF-FBFAX	FDA UDI	Class II	Unknown
Surveyor S12	SUR12-RAA-XXAAX	FDA UDI	Class II	Active
Eli 380	ELI380-DCS11	FDA UDI	Class II	Active
Patient Cable	9293-040-61	FDA UDI	Class II	Active
Surveyor Central	SCNODE-AAA-AXBEX	FDA UDI	Class II	Unknown
Surveyor Central	SCSYS-IAE-BBFAX	FDA UDI	Class II	Unknown
Patient Cable	9293-042-51	FDA UDI	Class II	Active
Surveyor S19	SUR19-BAA-XXAAX	FDA UDI	Class II	Unknown
Wam	41000-031-54	FDA UDI	Class II	Active
Monitoring Waveform Viewer	11093-002-50	FDA UDI	Class II	Active
Patient Cable Lead Set	9293-047-66	FDA UDI	Class II	Active
Q-Stress Patient Cable	60-00180-01	EUDAMEDFDA UDI	Class II	Active
Surveyor S12	SUR12-UAA-XXAAX	FDA UDI	Class II	Active
Eli 380	ELI380-DAX43	FDA UDI	Class II	Active
Q-Stress	QS6-MTTC1	FDA UDI	Class II	Active
Q-Stress	QS-6BD-ACAAB	FDA UDI	Class II	Active
Patient Cable Lead Set	9293-043-54	FDA UDI	Class II	Active
Am12m	9293-065-50	FDA UDI	Class II	Active
Eli 380	ELI380-DAS4X	FDA UDI	Class II	Active
ELI 250c	ELI250c-AAA-AAFAX	FDA UDI	Class II	Unknown
Ambulo 2400	ABP2400-BLA-AXXXX	FDA UDI	Class II	Unknown
Eli 280	ELI280-CAX-CDFBT	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-CAA-AAFAX	FDA UDI	Class II	Unknown
Surveyor Central	SCNODE-DAA-BXXEX	FDA UDI	Class II	Unknown
Q-Stress	QS6-BLXC1	FDA UDI	Class II	Active
Q-Stress	QS-6AA-CDEAA	FDA UDI	Class II	Active
Eli 380	ELI380-AAS21	FDA UDI	Class II	Active
Clear Choice Adapter	9325-003-50	FDA UDI	Class II	Active
Surveyor Central	SCSYS-IAE-FFFAX	FDA UDI	Class II	Unknown

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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