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CBL 6 Lead Set Grabber AAMI, ICU

by Philips Medizin Systeme Böblingen GmbH

Ref 989803145161

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

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
European UnionCE/MDR EUDAMED Number0884838BM556TE Basic UDI-DI Date18 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838021334 UDI-DI Date1 Aug 2017ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
CBL 6 Lead Set Grabber AAMI, ICU EUDAMED
6 Lead Set Grabber AAMI, ICU EUDAMED
ECG Cables and Leadsets GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
ECG Lead Sets
Model / Ref / Catalog
989803145161, CBL 6 Lead Set Grabber AAMI, ICU, 6 Lead Set Grabber AAMI
Primary DI / UDI-DI
00884838021334, 00884838123601
Basic UDI-DI
0884838BM556TE
510(k) Number
FDA Product Code
IKD, DSA
EMDN Code
Z1203020299, Z1203020280
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.1175, 870.2900
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00884838021334)
In Commercial Distribution (UDI-DI 00884838123601)
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
989803145161
GUDID
CBL 6 Lead Set Grabber AAMI, ICU
6 Lead Set Grabber AAMI, ICU
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No