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Short Neonatal ECG 2.0 Cable AAMI

by Philips Medizin Systeme Böblingen GmbH

Ref 9222

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 Number00884838120525 UDI-DI Date19 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1072M2 Basic UDI-DI 00884838120525UDI-DIDate16 May 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  • Withdrawn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
Short Neonatal ECG 2.0 Cable AAMI EUDAMED
MR Patient Care Short Neonatal ECG 2.0 Cable AAMI GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
Reusable Electrocardiographic Leads
Model / Ref / Catalog
9222, Short Neonatal ECG 2.0 Cable AAMI
Primary DI / UDI-DI
00884838120525
Basic UDI-DI
0884838BM1072M2
Direct Marketing DI
00884838120525
FDA Product Code
MWI
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2300
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
9222
GUDID
Short Neonatal ECG 2.0 Cable AAMI
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

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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