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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 1 of 17

Device	Model / Reference	Registries	Class	Status
ELI 150c	ELI150c-CAC-AEABX	FDA UDI	Class II	Active
SunTech Tango M2 Kit	9922-020-50	FDA UDI	Class II	Active
Surveyor S19	SUR19-NAA-XXAAX	FDA UDI	Class II	Unknown
Eli 280	BUR280-C1X	FDA UDI	Class II	Active
Eli 380	ELI380-AAX3X	FDA UDI	Class II	Active
HScribe	HSREV-AAA-BXXAA	FDA UDI	Class II	Unknown
E-Scribe	ESCRIBE-CAA-CXACB	FDA UDI	Class II	Unknown
Scribe	SCRIBEWS-5AC-XXXXX	FDA UDI	Class II	Active
Wam	41000-031-50	EUDAMEDFDA UDI	Class II	Active
XScribe Cardiopulmonary Kit	41000-030-62	FDA UDI	Class II	Active
Patient Cable Lead Set	9293-041-61	FDA UDI	Class II	Active
Surveyor S12	SUR12-TAA-XXAAX	FDA UDI	Class II	Active
Q-Stress	QSERV-6AA-XXXXB	FDA UDI	Class II	Active
Scribe	SCRIBEWS-5BB-YXXXX	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-MAA-ABBAX	FDA UDI	Class II	Unknown
RScribe	RSCRIBE-6GC-XXDAA	FDA UDI	Class II	Active
Eli 380	ELI380-DASXX	FDA UDI	Class II	Active
X12+	X12PLUS-BAA-XXXXX	FDA UDI	Class II	Unknown
Surveyor Central	SCNODE-GAA-XXDXX	FDA UDI	Class II	Unknown
Q-Tel RMS	33193-103-50	FDA UDI	Class II	Unknown
HScribe	HSCRIBE-6AB-AXXXB	FDA UDI	Class II	Unknown
Q-Stress	QS6-MXTCS	FDA UDI	Class II	Active
Eli 380	ELI380-DBX3X	FDA UDI	Class II	Active
XScribe	XSCRIBE-6AC-ACAXX	FDA UDI	Class II	Active
Surveyor Central	SCAC-AAA-DXDXX	FDA UDI	Class II	Unknown
ELI 250c	ELI250c-CAC-ADCAX	FDA UDI	Class II	Unknown
Eli 230	BUR230-A	FDA UDI	Class II	Active
Eli 380	ELI380-ACSXX	FDA UDI	Class II	Active
ELI 250c	BUR250c-W1D	FDA UDI	Class II	Unknown
Eli 280	ELI280-AAA-AAFBD	FDA UDI	Class II	Active
Eli 380	ELI380-DCX3X	FDA UDI	Class II	Active
RScribe	RSCRIBE-6AC-AXAAB	FDA UDI	Class II	Active
Modality Manager	MODALITYMGR-5AE-AXXXB	FDA UDI	Class II	Active
Eli 380	ELI380-ABX3X	FDA UDI	Class II	Active
Eli 380	ELI380-DAX21	FDA UDI	Class II	Active
Surveyor Central	SCSYS-IAE-TFFAX	FDA UDI	Class II	Unknown
Eli 380	ELI380-DBSXX	FDA UDI	Class II	Active
Surveyor Central	SCREV-AAA-BXXAX	FDA UDI	Class II	Unknown
Surveyor S12	SUR12-FAA-XXXAX	FDA UDI	Class II	Active
HScribe	HSCRIBE-5AA-AAXXX	FDA UDI	Class II	Unknown
Surveyor S12	SUR12-RAG-EXABX	FDA UDI	Class II	Unknown
ELI 250c	ELI250C-EAA-ABFBB	FDA UDI	Class II	Unknown
XScribe Patient Cable	9293-022-51	FDA UDI	Class II	Active
HScribe	HSCRIBEWS-6AC-YXXXX	FDA UDI	Class II	Active
ELI 250c	ELI250c-EAA-AAAAX	FDA UDI	Class II	Unknown
XScribe	XSCRIBE-6BB-AAAXA	FDA UDI	Class II	Active
Am12	9293-048-65	EUDAMEDFDA UDI	Class II	Active
RScribe	RSCRIBE-6AC-XXAAA	FDA UDI	Class II	Active
Surveyor S12	SUR12-SAG-FXABX	FDA UDI	Class II	Unknown
Eli 280	ELI280-AAA-AAAAX	FDA UDI	Class II	Active

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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