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Simcheck

by Scienco Technology Corp. 3 variants

Ref 4713616865036Model DS-5

Active European Union

CE IVDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04713616865036 Basic UDI-DI 04713616865036UDI-DIDate4 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
SIMCHECK DS-5 Blood Glucose Meter
Model / Reference
DS-5, 4713616865036
Primary DI / UDI-DI
04713616865036
Basic UDI-DI
B-04713616865036
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class IVD Annex II List B
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TW-MF-000043119
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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See all devices from Scienco Technology Corp. →

Properties

  • Self Testing
  • Professional Testing
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No