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Solid Gel Tab Electrode, Resting ECG

by Philips Medizin Systeme Böblingen GmbH

Ref 13943BModel Electrocardiographic Electrodes Lang

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM1636MU Basic UDI-DI 20884838116164UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20884838116164 UDI-DI Date17 Oct 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  • Withdrawn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
Solid Gel Tab Electrode, Resting ECG EUDAMED
ECG Electrodes GUDID
Generic Name
Electrocardiographic electrode, single-use
Device Name
Electrocardiographic Electrodes Lang
Model / Ref / Catalog
Electrocardiographic Electrodes Lang, 13943B, Solid Gel Tab Electrode, Resting ECG
Primary DI / UDI-DI
20884838116164
Basic UDI-DI
0884838BM1636MU
Unit of Use DI
00884838116160
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
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Electrocardiographic Electrodes Lang
13943B
GUDID
Solid Gel Tab Electrode, Resting ECG
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

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Properties

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

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No