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Tc Additional Leads Kit: Iec

by Philips Medizin Systeme Böblingen GmbH EUDAMEDGUDID

Active European Union

Ref 989803151761Model Lead Set/Patient Cable/Lead Upgrade Kit

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838117280 UDI-DIDate4 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1861N5 Basic UDI-DIDate15 Dec 2025RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Tc Additional Leads Kit: Iec EUDAMED
patient lead wire GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
Lead Set/Patient Cable/Lead Upgrade Kit
Model / Ref / Catalog
Lead Set/Patient Cable/Lead Upgrade Kit, 989803151761, TC ADDITIONAL LEADS KIT: IEC
Primary DI / UDI-DI
00884838117280
Basic UDI-DI
0884838BM1861N5
FDA Product Code
DPS
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2340
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Lead Set/Patient Cable/Lead Upgrade Kit
989803151761
GUDID
TC ADDITIONAL LEADS KIT: IEC
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Related devices

Category: Electrocardiographic lead set, reusable

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No
  • Manufacturing Date: No