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ImPACT

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref ImPACT

by ImPACT Applications, Inc.

Identity

Trade Name
ImPACT EUDAMEDFDA UDI
ImPACT Version 4 FDA UDI
Generic Name
Cognitive assessment software FDA UDI
Cause-and-effect assistive training device FDA UDI
Device Name
ImPACT EUDAMED
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80. FDA UDI
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59. FDA UDI
Model / Reference
ImPACT EUDAMEDFDA UDI
4 FDA UDI
Description
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80. FDA UDI
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59. FDA UDI

Identifiers

Primary DI / UDI-DI
00864127000349 EUDAMEDFDA UDI
00864127000301 FDA UDI
Basic UDI-DI
08641270003impactcognit9L EUDAMED
510(k) Number
DEN150037 FDA UDI
FDA Product Code
POM FDA UDI
EMDN Code
Z12109092 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Cognitive assessment software FDA UDI
Cause-and-effect assistive training device FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.1471 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

ImPACT by ImPACT Applications, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
ImPACT Applications, Inc.
EUDAMED SRN
US-MF-000002776
Authorised Representative
Advena Limited MT-AR-000000234

Sources (4)

  • EUDAMED 365df15d-3b46-4c51-8dbb-33ffbdb145a9 61 fields · synced Jul 19, 2026
  • FDA UDI 7701f610-cfdd-4212-817f-e04677a7ea55 34 fields · synced May 29, 2026
  • FDA UDI ddef2d87-f576-4996-ac54-074f18a63867 36 fields · synced May 30, 2026
  • FDA 510(k) K181223 1 fields · synced May 18, 2026