Natus Quantum 10-10/10-20 Pin Box

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 017048

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

Identity

Trade Name: Natus Quantum 10-10/10-20 Pin Box EUDAMED
Natus FDA UDI
Generic Name: Electrical-only medical device connection cable, reusable FDA UDI
Device Name: Quantum II Class I Accessories EUDAMED
Natus Quantum 10-10/10-20 Pin Box FDA UDI
Model / Reference: 017048 EUDAMEDFDA UDI
Description: Natus Quantum 10-10/10-20 Pin Box FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830016780 EUDAMEDFDA UDI
Basic UDI-DI: 038283NA00057EG EUDAMED
Direct Marketing DI: 00382830016780 EUDAMED
FDA Product Code: GXY FDA UDI
EMDN Code: Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Natus Quantum 10-10/10-20 Pin Box 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	038283NA00057EG	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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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 53499e58-772a-4cee-867a-7a9c804f1477 61 fields · synced Jun 18, 2026
FDA UDI 05c15e1f-d470-4a89-84a8-350ec2be262c 33 fields · synced May 30, 2026