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Sonicure SC43C+

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

Ref SC43C+

Sonicure SC43C+ is a device classified as Class IIb (EU), Unclassified (US) made by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 697230475000977), cleared under FDA 510(k) K212614 on 18 Jul 2022 and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 16972304750480), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212614

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/MDR EUDAMED Number697230475000977 Basic UDI-DI 16972304750480UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number16972304750480 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212614 Date18 Jul 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697230475000977 registered 13 May 2026 Active
  • FDA 510(k) K212614 decided 18 Jul 2022 Active
  • FDA GUDID UDI-DI 16972304750480 listed 26 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212614
  2. Listed FDA GUDID 16972304750480
  3. Registered EUDAMED 697230475000977

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  • Withdrawn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 scalpel EUDAMED
Sonicure GUDID
Generic name
Soft-tissue ultrasonic surgical system
Model / reference
SC43C+
Primary DI / UDI-DI
16972304750480
Basic UDI-DI
697230475000977
510(k) Number
FDA product code
LFL
EMDN code
Z12010801 Ultrasonic scalpel
GMDN term
Soft-tissue ultrasonic surgical system
Device class
Class IIb EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
U
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 16972304750480: EUDAMED states No, FDA GUDID states Yes.

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

Related devices

Category: Soft-tissue ultrasonic surgical system

Cleared under the same submission (K212614)

and 2 more cleared under K212614

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ULTRASONIC SURGERY.

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

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

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)