Skip to content

6-Lead Set, Disposable, Bedside IEC

by Philips Medizin Systeme Böblingen GmbH Germany EUDAMEDGUDID

Ref 989803197521Model Single Patient Use Disposable "Sparrow" Product code DSAEMDN Z1203020299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM1101LG Basic UDI-DIDate2 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number20884838114061 UDI-DIDate16 Sep 2024ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
6-Lead Set, Disposable, Bedside IEC EUDAMED
Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets GUDID
Generic Name
Electrocardiographic lead set, single-use
Device Name
Single Patient Use Disposable "Sparrow"
Model / Ref / Catalog
Single Patient Use Disposable "Sparrow", 989803197521, 6-Lead Set, Disposable, Bedside IEC
Primary DI / UDI-DI
20884838114061
Basic UDI-DI
0884838BM1101LG
Unit of Use DI
00884838114067
FDA Product Code
DSA
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Electrocardiographic lead set, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Single Patient Use Disposable "Sparrow"
989803197521
GUDID
6-Lead Set, Disposable, Bedside IEC
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

See all devices from Philips Medizin Systeme Böblingen GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
Other properties (21)
  • 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
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED fbcb7aff-ec17-4516-aaeb-7f5b6643c236 61 fields · synced 22 Oct 2026
  • FDA UDI 7843ec93-2b22-48d9-a680-b4f3321c573a 35 fields · synced 30 May 2026