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Diacore

by SHENB Co., Ltd.

Ref High-frequency electromagnetic stimulatorModel DIACORE

Diacore is a medical device (EU MDR Class IIa; EMDN category muscle stimulators) made by shenb Co., Ltd., cleared under FDA 510(k) K253926 on 10 Apr 2026 and registered in EUDAMED on 26 Jul 2023 (Basic UDI-DI 88000171SH016CH), active as of 24 Oct 2026.

Active European Union and United States

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253926↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK253926 Date10 Apr 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number88000171SH016CH Basic UDI-DI 08800017101361UDI-DIDate26 Jul 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253926 decided 10 Apr 2026 Active
  • EUDAMED Basic UDI-DI 88000171SH016CH registered 26 Jul 2023 Active

Timeline

2 dated events

  1. Registered EUDAMED 88000171SH016CH
  2. Cleared FDA 510(k) K253926

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
DIACORE, High-frequency electromagnetic stimulator
Primary DI / UDI-DI
08800017101361
Basic UDI-DI
88000171SH016CH
EMDN code
Z120622 Muscle stimulators
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000021619
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under MUSCLE STIMULATORS.

Other devices from shenb Co., Ltd.

See all devices from shenb Co., Ltd. →

Properties

Other properties (14, all answered No)