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ISE PUFR, 1 x 5000 ml

by SKALAB s.r.o.

Ref B 01-4171-58

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number859421408SKAIVDP4 Basic UDI-DI 08594214080061UDI-DIDate2 Feb 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Alkalický promývací roztok
Model / Reference
B 01-4171-58
Primary DI / UDI-DI
08594214080061
Basic UDI-DI
859421408SKAIVDP4
Direct Marketing DI
08594214080061
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000029744

Other devices from SKALAB s.r.o.

See all devices from SKALAB s.r.o. →

Properties

  • Companion Diagnostics

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Surgical Instrument: No
  • New Device: No