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Paraffin Wax 56-58 °C, 5 Kg

by Biyosistem Medikal Limited Sirketi

Ref HPR-WAX-005KModel HistoPlus

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868182038WAXTU Basic UDI-DI 08681820380880UDI-DIDate11 May 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  • Withdrawn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
Paraffin for Histology 56-58 °C
Model / Reference
HistoPlus, HPR-WAX-005K
Primary DI / UDI-DI
08681820380880
Basic UDI-DI
868182038WAXTU
Direct Marketing DI
08681820380880
EMDN Code
W01030704 Embedding media (histology/cytology)
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000037366

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Properties

Other properties (11)

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