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Patient Events Button 8’

EUDAMEDFDA UDI

Class I (EU MDR)

Ref W6232H

by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)

Identity

Trade Name
Patient Events Button 8’ EUDAMED
Natus FDA UDI
Generic Name
Analytical non-scalp cutaneous lead FDA UDI
Device Name
Patient Event Button Neuro EUDAMED
PATIENT EVENT BUTTON 8FT FDA UDI
Model / Reference
W6232H EUDAMEDFDA UDI
Description
PATIENT EVENT BUTTON 8FT FDA UDI

Identifiers

Primary DI / UDI-DI
00382830000147 EUDAMEDFDA UDI
Basic UDI-DI
038283NA00035E6 EUDAMED
Direct Marketing DI
00382830000147 EUDAMED
FDA Product Code
GWQ FDA UDI
EMDN Code
Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
GMDN Term
Analytical non-scalp cutaneous lead FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Patient Events Button 8’ by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)
EUDAMED SRN
CA-MF-000004001
Authorised Representative
Natus Manufacturing Ltd IE-AR-000000884

Sources (2)

  • EUDAMED 79f94d06-068c-4ea8-9d06-dceda955c6a5 61 fields · synced Jun 18, 2026
  • FDA UDI 03c11012-a979-4abf-8be1-6b17b627df25 33 fields · synced May 30, 2026