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XperGuide laser tool

by Philips Medical Systems Nederland B.V. 3 variants

Ref 452212923724

Active Active in United States. Withdrawn in European Union.

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131263↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM800T2 Basic UDI-DI 00884838107014UDI-DIDate3 Sep 2024RegisteredStatusWithdrawn No longer placed on the EU market
United StatesFDA 510(k) 510(k) NumberK131263 Date24 Jul 2013IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDR Withdrawn

Specification

EUDAMED · 510(k)

Device Name
Laser accessories
Model / Reference
452212923724
Primary DI / UDI-DI
00884838107014
Basic UDI-DI
0884838BM800T2
EMDN Code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
Device Class
Class I

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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Properties

Other properties (13)

  • 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