Skip to content

S-Patch Ex

by Wellysis Corp.

Ref S-Patch Ex

S-Patch Ex is a medical device (EU MDD Class IIa; EMDN category general purpose electrocardiographs) made by Wellysis Corp., registered in EUDAMED on 18 Aug 2022 (Basic UDI-DI B-8800159510000ZC), active as of 23 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8800159510000ZC Basic UDI-DI D-8800159510000ZCUDI-DIDate18 Aug 2022RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
S-Patch Ex
Model / reference
S-Patch Ex
Primary DI / UDI-DI
D-8800159510000ZC
Basic UDI-DI
B-8800159510000ZC
EMDN code
Z12050301 General purpose electrocardiographs
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
KR-MF-000027374
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under GENERAL PURPOSE ELECTROCARDIOGRAPHS.

Other devices from Wellysis Corp.

  • S-Patch CardioAI

    Class II

  • S-Patch Ex 0

    Class II

  • S-Patch ExL 0

    Class II

  • S-Patch (S-Patch ExL)

    Class II

See all devices from Wellysis Corp. →

Properties

Other properties (12, all answered No)