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Single Patch ECG Electrodes (25)

by Philips Medizin Systeme Böblingen GmbH

Ref 989803179031

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM1071LY Basic UDI-DI 10884838117836UDI-DIDate21 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10884838117836 UDI-DI Date21 May 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Single Patch ECG Electrodes (25) EUDAMED
MR Patient Care Single Patch ECG Electrodes (25) GUDID
Generic Name
Electrocardiographic electrode, single-use
Device Name
Single use Electrocardiographic Electro
Model / Ref / Catalog
989803179031, Single Patch ECG Electrodes (25)
Primary DI / UDI-DI
10884838117836
Basic UDI-DI
0884838BM1071LY
Unit of Use DI
00884838117839
FDA Product Code
DRX
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Electrocardiographic electrode, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2360
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
989803179031
GUDID
Single Patch ECG Electrodes (25)
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No