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Neonatal ECG Electrodes (25)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989803179051

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
Neonatal ECG Electrodes (25) EUDAMED
MR Patient Care Neonatal ECG Electrodes (25) FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
Single use Electrocardiographic Electro EUDAMED
ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX FDA UDI
Model / Reference
989803179051 EUDAMED
Neonatal ECG Electrodes (25) FDA UDI
Description
ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX FDA UDI

Identifiers

Catalog Number
989803179051 FDA UDI
Primary DI / UDI-DI
10884838117850 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM1071LY EUDAMED
Unit of Use DI
00884838117853 EUDAMED
FDA Product Code
DRX FDA UDI
EMDN Code
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
GMDN Term
Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Neonatal ECG Electrodes (25) by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH
EUDAMED SRN
DE-MF-000006026

Sources (2)

  • EUDAMED 603c0961-b5ce-4137-ae4d-73c985963911 61 fields · synced Jul 11, 2026
  • FDA UDI a6055f38-3890-4707-ac33-2377065bc517 35 fields · synced May 29, 2026