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Aesculap GN200

by Aesculap AG

Ref GN200

Aesculap GN200 is an electrosurgical system generator (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Aesculap AG, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 40392390000027973R) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04046964013638), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000027973R Basic UDI-DI 04046964013638UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964013638 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000027973R registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 04046964013638 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046964013638
  2. Registered EUDAMED 40392390000027973R

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  • Withdrawn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
Lektrafuse EUDAMED
Aesculap GUDID
Generic name
Electrosurgical system generator
Device name
LEKTRAFUSE HF generator
Model / Ref / Catalog
GN200
Primary DI / UDI-DI
04046964013638
Basic UDI-DI
40392390000027973R
FDA product code
GEI
EMDN code
Z12010904 Endoscopic electrosurgical units (esu)
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
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.

Related devices

Category: Electrosurgical system generator

Other devices from Aesculap AG

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)