Skip to content

PW CBL Long Complete Lead Set IEC

by Philips Medizin Systeme Böblingen GmbH

Ref 989803151661Model Lead Set/Patient Cable/Lead Upgrade Kit

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 linked in EUDAMED

A group certificate may exist

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
United StatesGUDID listing GUDID Number00884838117228 UDI-DI Date16 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1861N5 Basic UDI-DI 00884838117228UDI-DIDate15 Dec 2025RegisteredStatusActive

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.

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  • Withdrawn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
PW CBL Long Complete Lead Set 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, 989803151661, PW CBL Long Complete Lead Set IEC
Primary DI / UDI-DI
00884838117228
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
EU 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
989803151661
GUDID
PW CBL Long Complete Lead Set 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

See all devices from Philips Medizin Systeme Böblingen GmbH →

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