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Integra® NL8501214

by Integra Lifesciences Corp.

Ref NL8501214

Integra® NL8501214 is a device classified as Class III in the EU and Class II in the US made by Integra Lifesciences Corp., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-10381780024231) and listed in FDA GUDID since 15 Dec 2016 (UDI-DI 10381780024231), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780024231 Basic UDI-DI 10381780024231UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780024231 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780024231 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 10381780024231 listed 15 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780024231
  2. Registered EUDAMED B-10381780024231

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Integra®
Generic name
Cerebrospinal fluid shunt valve
Device name
CSF Drainage Systems
Model / Ref / Catalog
NL8501214
Primary DI / UDI-DI
10381780024231
Basic UDI-DI
B-10381780024231
FDA product code
JXG
EMDN code
C0180 Artero-venous system devices - accessories not included in other classes
GMDN term
Cerebrospinal fluid shunt valve
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Cerebrospinal fluid shunt valve

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)