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Single Patch ECG Electrodes (25)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989803179031

by Invivo, a division of Philips Medical Systems

Identity

Trade Name
Single Patch ECG Electrodes (25) EUDAMED
MR Patient Care Single Patch ECG Electrodes (25) FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
Single use Electrocardiographic Electro EUDAMED
QUADTRODE MRI ECG PAD,25/BOX FDA UDI
Model / Reference
989803179031 EUDAMED
Single Patch ECG Electrodes (25) FDA UDI
Description
QUADTRODE MRI ECG PAD,25/BOX FDA UDI

Identifiers

Catalog Number
989803179031 FDA UDI
Primary DI / UDI-DI
10884838101927 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM454T5 EUDAMED
Unit of Use DI
00884838101920 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
Not 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

No

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

Dimensions & Sizes

Size
Length — 99.000 Millimeter FDA UDI
Width — 99.000 Millimeter FDA UDI

Single Patch ECG Electrodes (25) by Invivo, a division of Philips Medical Systems — 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
Invivo, a division of Philips Medical Systems
EUDAMED SRN
US-MF-000002177
Authorised Representative
Philips Medizin Systeme Böblingen GmbH DE-AR-000006030

Sources (2)

  • EUDAMED 482c2aae-3423-45bf-93ed-66bf9bd037a1 61 fields · synced Jun 19, 2026
  • FDA UDI ad3cfcd0-35fb-4b16-8797-8b86760cd679 38 fields · synced May 29, 2026