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Enseal NSLX145C

by Ethicon Endo-Surgery, LLC

Ref NSLX145C

Enseal NSLX145C is a device classified as Class IIb in the EU and Class II in the US made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 9 Sep 2025 (Basic UDI-DI 0705036a0008578) and listed in FDA GUDID since 20 Feb 2019 (UDI-DI 10705036015499), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a0008578 Basic UDI-DI 10705036015499UDI-DIDate9 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036015499 UDI-DI Date20 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705036a0008578 registered 9 Sep 2025 Active
  • FDA GUDID UDI-DI 10705036015499 listed 20 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10705036015499
  2. Registered EUDAMED 0705036a0008578

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  • Withdrawn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
Enseal
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Model / Ref / Catalog
NSLX145C
Primary DI / UDI-DI
10705036015499
Basic UDI-DI
0705036a0008578
FDA product code
GEI, HGI
EMDN code
K0201010201, K0201010202
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400, 884.4120
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)