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Licox® BC10R

by Integra Lifesciences (Ireland) Limited

Part of a family of 24 devices: see the family page

Ref BC10R

Licox® BC10R is a device classified as Class I in the EU and Class II in the US made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 038178B0036CSS3D), cleared under FDA 510(k) K002765 on 24 Nov 2000 and listed in FDA GUDID since 2 Aug 2016 (UDI-DI 10381780250111), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K002765

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0036CSS3D Basic UDI-DI 10381780250111UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780250111 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK002765 Date24 Nov 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038178B0036CSS3D registered 8 Jul 2026 Active
  • FDA 510(k) K002765 decided 24 Nov 2000 Active
  • FDA GUDID UDI-DI 10381780250111 listed 2 Aug 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0831-2015 FDA Class II initiated 7 Nov 2014

    Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

    • Terminated Z-1518-2011 FDA Unclassified (pre-2012) initiated 17 Dec 2010

    Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.

    • Terminated Z-0622-05 FDA Unclassified (pre-2012) initiated 21 Jan 2005 on shared 510(k) K002765

    LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K002765
  2. Recall initiated FDA recalls Z-0622-05
  3. Recall initiated FDA recalls Z-1518-2011
  4. Recall initiated FDA recalls Z-0831-2015
  5. Listed FDA GUDID 10381780250111
  6. Registered EUDAMED 038178B0036CSS3D

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Licox®
Generic name
Transistor tester
Device name
lntegra Monitor cables
Model / Ref / Catalog
BC10R
Primary DI / UDI-DI
10381780250111
Basic UDI-DI
038178B0036CSS3D
510(k) Number
FDA product code
GWM
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Transistor tester
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1620
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Transistor tester

Cleared under the same submission (K002765)

and 6 more cleared under K002765

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)