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Sanasol

by Sanasol Meditechnika Kft. 15 variants

Ref 2012Model SM-01 Sweat Collector and Measurement Probe Kit

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05998221335221 Basic UDI-DI 05998221335221UDI-DIDate23 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
SM-01 Sweat Collector and Measurement Probe Kit
Model / Reference
SM-01 Sweat Collector and Measurement Probe Kit, 2012
Primary DI / UDI-DI
05998221335221
Basic UDI-DI
B-05998221335221
EMDN Code
Z12080408 Sweat test stimulators
Device Class
Class IVD General
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000019795

Other devices from Sanasol Meditechnika Kft.

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Properties

  • Professional Testing

Other properties (9)

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