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Varicure ES300

by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Part of a family of 36 devices: see the family page

Ref ES300

Varicure ES300 is a device classified as Class IIb in the EU and Class II in the US made by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 69723047500046V), cleared under FDA 510(k) K210488 on 25 Oct 2021 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 06972304750728), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210488

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69723047500046V Basic UDI-DI 06972304750728UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972304750728 UDI-DI Date27 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210488 Date25 Oct 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69723047500046V registered 13 May 2026 Active
  • FDA 510(k) K210488 decided 25 Oct 2021 Active
  • FDA GUDID UDI-DI 06972304750728 listed 27 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210488
  2. Listed FDA GUDID 06972304750728
  3. Registered EUDAMED 69723047500046V

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ultrasonic Surgical & Electrosurgical Generator EUDAMED
Varicure GUDID
Generic name
Electrosurgical/ultrasonic surgical system generator
Device name
Ultrasonic Surgical& Electrosurgical System
Model / reference
ES300
Primary DI / UDI-DI
06972304750728
Basic UDI-DI
69723047500046V
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical/ultrasonic surgical 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

Cleared under the same submission (K210488)

and 1 more cleared under K210488

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

See all devices from Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)