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As Software, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
560 Sylvan Ave, Englewood Cliffs, NJ, 07632
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3005207094
DUNS Number
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Catalogue (3)

DeviceModel / ReferenceRegistriesClassStatus
As-Emr System; As-Obgyn Information System 10
FDA UDI
Class IIActive
AS Software Version Asera K260205
FDA 510(k)
Class IIActive
As-Obgyn Information System; As-Emr System K051639
FDA 510(k)
Class IIActive

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 (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Sep 20, 2018Z-0118-2019—terminated

Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system