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5-Lead Set, Disposable, Chest, Aami

by Philips Medizin Systeme Böblingen GmbH

Ref 989803192141Model Single Patient Use Disposable "Sparrow"

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 Number0884838BM1101LG Basic UDI-DI 20884838114078UDI-DIDate2 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number20884838114078 UDI-DI Date16 Sep 2024ListedStatusListed 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  • Withdrawn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
5-Lead Set, Disposable, Chest, Aami 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", 989803192141, 5-LEAD SET, DISPOSABLE, CHEST, AAMI
Primary DI / UDI-DI
20884838114078
Basic UDI-DI
0884838BM1101LG
Unit of Use DI
00884838114074
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
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Single Patient Use Disposable "Sparrow"
989803192141
GUDID
5-LEAD SET, DISPOSABLE, CHEST, AAMI
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

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