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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 8 of 17

Device	Model / Reference	Registries	Class	Status
HScribe	HSCRIBWS-6BC-YXXXX	FDA UDI	Class II	Active
Eli 380	ELI380-DAS3X	FDA UDI	Class II	Active
Quik-Prep	011440-005	FDA UDI	Class II	Active
HeartCentrix	11098-002-50	FDA UDI	Class II	Active
E-Scribe	ESWKST-EAA-BXXXX	FDA UDI	Class II	Unknown
Surveyor Central	SCSYS-IAE-ABFAX	FDA UDI	Class II	Unknown
Surveyor S12	SUR12-QAC-XXAAX	FDA UDI	Class II	Unknown
Surveyor Central	SCSYS-IAE-AFFAX	FDA UDI	Class II	Unknown
Eli 280	MLBUR280-81D	FDA UDI	Class II	Active
Wam	30012-020-60	FDA UDI	Class II	Unknown
Eli 380	ELI380-ABX4X	FDA UDI	Class II	Active
ELI 250c	BUR250c-C1D	FDA UDI	Class II	Unknown
Patient Cable Lead Set	9293-041-57	FDA UDI	Class II	Active
Eli 380	ELI380-FCS11	FDA UDI	Class II	Active
Surveyor Central	SCREP-AAA-XXXXX	FDA UDI	Class II	Unknown
Patient Cable Lead Set	9293-046-60	FDA UDI	Class II	Active
Surveyor Patient Cable	9293-061-50	FDA UDI	Class II	Active
XScribe	XSERV-6AA-XXXXX	FDA UDI	Class II	Active
ELI 250c	ELI250c-MAC-AEHBB	FDA UDI	Class II	Unknown
CardioConfirm	11111-003-51	FDA UDI	Class II	Active
Patient Cable	9293-040-51	FDA UDI	Class II	Active
ELI 250c	BUR250c-W1X	FDA UDI	Class II	Unknown
Am12	41000-032-52	FDA UDI	Class II	Active
RScribe	RSCRIBE-6CC-AXCAA	FDA UDI	Class II	Active
Wam	41000-031-52	FDA UDI	Class II	Active
Patient Cable	9293-017-50	FDA UDI	Class II	Active
Surveyor Central	SCNODE-BAA-EMXEX	FDA UDI	Class II	Unknown
Surveyor Central	SCSYS-IAE-BFFAX	FDA UDI	Class II	Unknown
Eli 380	ELI380-DAS11	FDA UDI	Class II	Active
Eli 380	ELI380-ABSXX	FDA UDI	Class II	Active
Surveyor S12	SUR12-PAA-XXAAX	FDA UDI	Class II	Unknown
Surveyor Central	SCNODE-DAA-CKXEX	FDA UDI	Class II	Unknown
ELI 150c	ELI150c-CAA-AAHAX	FDA UDI	Class II	Active
Eli 280	ELI280-CXX-ADFBD	FDA UDI	Class II	Active
Surveyor Central	SCSYS-HAE-RHFAA	FDA UDI	Class II	Unknown
HScribe	HSCRIBE-6AA-AAXXB	FDA UDI	Class II	Unknown
ELI 150c	ELI150c-IAA-AFHAB	FDA UDI	Class II	Unknown
HScribe	HSCRIBE-5AB-AXXXD	FDA UDI	Class II	Unknown
Surveyor S19	SUR19-RAA-XXXAX	FDA UDI	Class II	Unknown
Surveyor Central	SCSYS-HAE-SHFCX	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-EDA-ABCAX	FDA UDI	Class II	Unknown
ELI 150c	ELI150c-AAA-AACAD	FDA UDI	Class II	Active
Surveyor S4	S4-P-A	FDA UDI	Class II	Active
Q-Stress	QS-6ID-AGDAA	FDA UDI	Class II	Active
Scribe	SCRIBEWS-5AC-AXXXX	FDA UDI	Class II	Unknown
Holter Prep Kit	XKTHOLT5LA	FDA UDI	Class II	Unknown
Am12q	9293-062-50	FDA UDI	Class II	Active
RScribe	RSCRIBE-6BC-XXDXX	FDA UDI	Class II	Active
ELI 150c	ELI150c-GAA-ABHAX	FDA UDI	Class II	Active
Eli 280	ELI280-CAA-AAFAD	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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