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Telemetry Accessories ECG 5 lead Snaps, AAMI, Tele

by Philips Medizin Systeme Böblingen GmbH

Ref 989803171821Model Lead sets w/wo SpO2 adapter and Cables

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838119024 UDI-DI Date28 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1910MR Basic UDI-DI 00884838119024UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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
ECG 5 lead Snaps, AAMI, Tele EUDAMED
Telemetry Accessories GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
Lead sets w/wo SpO2 adapter and Cables
Model / Ref / Catalog
Lead sets w/wo SpO2 adapter and Cables, 989803171821, ECG 5 lead Snaps, AAMI, Tele
Primary DI / UDI-DI
00884838119024
Basic UDI-DI
0884838BM1910MR
FDA Product Code
MHX
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1025
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
Lead sets w/wo SpO2 adapter and Cables
989803171821
GUDID
ECG 5 lead Snaps, AAMI, Tele
Device ClassEUDAMED
Class I
GUDID
Class II

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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