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Dophi SJ-B02

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

Ref SJ-B02

Dophi SJ-B02 is a foot-switch (EU MDR Class I; FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 69723047500116S), cleared under FDA 510(k) K183153 on 8 Jul 2019 and listed in FDA GUDID since 19 Jan 2022 (UDI-DI 06972304751435), 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) K183153

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 Number69723047500116S Basic UDI-DI 06972304751435UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972304751435 UDI-DI Date19 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183153 Date8 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69723047500116S registered 13 May 2026 Active
  • FDA 510(k) K183153 decided 8 Jul 2019 Active
  • FDA GUDID UDI-DI 06972304751435 listed 19 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183153
  2. Listed FDA GUDID 06972304751435
  3. Registered EUDAMED 69723047500116S

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  • Withdrawn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
Foot Switch EUDAMED
Dophi GUDID
Generic name
Foot-switch, electrical
Model / reference
SJ-B02
Primary DI / UDI-DI
06972304751435
Basic UDI-DI
69723047500116S
510(k) Number
FDA product code
NEY
EMDN code
Z120608 Microwave therapy equipment
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Foot-switch, electrical

Cleared under the same submission (K183153)

and 4 more cleared under K183153

Similar devices in this category

Other devices filed under MICROWAVE THERAPY EQUIPMENT.

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
Other properties (22, all answered No)