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Finesse+, 230VAC

by Utah Medical Products, Inc.

Ref FIN-220Model Finesse+

Finesse+, 230VAC (FIN-220) is a device classified as Class IIb in the EU and Class II in the US made by Utah Medical Products, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-H671FIN2200), cleared under FDA 510(k) K123310 on 23 Jan 2013 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H671FIN2200), active as of 23 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123310

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/MDD EUDAMED NumberB-H671FIN2200 Basic UDI-DI H671FIN2200UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberH671FIN2200 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123310 Date23 Jan 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-H671FIN2200 registered 27 May 2026 Active
  • FDA 510(k) K123310 decided 23 Jan 2013 Active
  • FDA GUDID UDI-DI H671FIN2200 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123310
  2. Listed FDA GUDID H671FIN2200
  3. Registered EUDAMED B-H671FIN2200

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Finesse+ EUDAMED
Finesse GUDID
Generic name
Electrosurgical system generator
Model / Ref / Catalog
Finesse+, FIN-220, 230VAC
Primary DI / UDI-DI
H671FIN2200
Basic UDI-DI
B-H671FIN2200
510(k) Number
FDA product code
GEI, HGI
EMDN code
L1899, Z12080399
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400, 884.4120
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Finesse+
FIN-220
GUDID
Finesse+, 230VAC
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

Cleared under the same submission (K123310)

Similar devices in this category

Other devices filed under VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER.

Other devices from Utah Medical Products, Inc.

See all devices from Utah Medical Products, Inc. →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)