Scribe

FDA UDI

Class II (US FDA UDI)

by Mortara Instrument, Inc.

Identity

Trade Name: Scribe FDA UDI
Generic Name: Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Device Name: Cardiology Information System Workstation FDA UDI
Model / Reference: SCRIBEWS-5AC-XXXXX FDA UDI
Description: Cardiology Information System Workstation FDA UDI

Identifiers

Primary DI / UDI-DI: 00817655020587 FDA UDI
FDA Product Code: MLO FDA UDI
DPS FDA UDI
GMDN Term: Electrocardiographic long-term ambulatory recording analyser application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2800 FDA UDI
870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiograph, professional, multichannel Electrocardiographic long-term ambulatory recording analyser application software Cardiac stress exercise monitoring system

Scribe by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mortara Instrument, Inc.

Sources (1)

FDA UDI 512b8389-5d75-4312-b092-5d7eb1976ac4 35 fields · synced May 31, 2026