← Back to catalogue

Avalon ECG/IUP Transducer

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 867247

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
Avalon ECG/IUP Transducer EUDAMEDFDA UDI
Generic Name
Patient monitoring system module, multifunction FDA UDI
Device Name
Avalon ECG/IUP Transducer EUDAMED
The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates FDA UDI
Model / Reference
867247 EUDAMED
Avalon ECG/IUP Transducer FDA UDI
Description
The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates FDA UDI

Identifiers

Catalog Number
867247 FDA UDI
Primary DI / UDI-DI
00884838093201 EUDAMEDFDA UDI
Basic UDI-DI
B-00884838093201 EUDAMED
FDA Product Code
HGM FDA UDI
DQA FDA UDI
DRG FDA UDI
DRQ FDA UDI
DXQ FDA UDI
DRS FDA UDI
DRT FDA UDI
JOM FDA UDI
DSA FDA UDI
DSF FDA UDI
DSI FDA UDI
DXG FDA UDI
HFM FDA UDI
MSX FDA UDI
FLL FDA UDI
DSJ FDA UDI
HFN FDA UDI
DXN FDA UDI
DSK FDA UDI
HGL FDA UDI
EMDN Code
Z1208010499 CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER EUDAMED
GMDN Term
Patient monitoring system module, multifunction FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
884.2740 FDA UDI
870.2700 FDA UDI
870.2910 FDA UDI
870.2060 FDA UDI
870.1120 FDA UDI
870.2850 FDA UDI
870.2300 FDA UDI
870.2780 FDA UDI
870.2900 FDA UDI
870.2810 FDA UDI
870.1025 FDA UDI
870.1435 FDA UDI
884.2720 FDA UDI
880.2910 FDA UDI
870.1100 FDA UDI
884.2700 FDA UDI
870.1130 FDA UDI
870.1110 FDA UDI
884.2960 FDA UDI
Market of Registration
Austria 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Avalon ECG/IUP Transducer by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (2)

  • EUDAMED d6cedf8a-cb07-4806-8851-2daa53b85961 61 fields · synced Jun 18, 2026
  • FDA UDI 02c1b948-c916-4bb6-a7ba-296959f326e7 36 fields · synced May 30, 2026