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Consumable Pack (Sheath, Obturator & Manifold) LX1-CSB-201

by Surgease Innovations Limited

Ref LX1-CSB-201Model LumenEye X1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506076828LUX1EY Basic UDI-DI 05060768280231UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060768280231 UDI-DI Date13 May 2026ListedStatusListed GUDID: 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 24 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  • Withdrawn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
LumenEye® X1 Consumable EUDAMED
Consumable Pack (Sheath, Obturator & Manifold) GUDID
Generic Name
Endoscope sheath, single-use
Device Name
LumenEye X1
Model / Ref / Catalog
LX1-CSB-201, LumenEye X1
Primary DI / UDI-DI
05060768280231
Basic UDI-DI
506076828LUX1EY
510(k) Number
FDA Product Code
FAN
EMDN Code
T030102 Cover sheaths, instruments and equipments
GMDN Term
Endoscope sheath, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K232262)

Other devices from Surgease Innovations Limited

See all devices from Surgease Innovations Limited →

Properties

  • Single Use
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: 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