Skip to content

StratoBlade

by OPTA-TECH Sp. z o.o. Poland EUDAMED

Ref SB-HModel StratoBlade H (SB-H)

EMDN W0202059085

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5905817273SBHEQ Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Microtome Blades StratoBlade H
Model / Reference
StratoBlade H (SB-H), SB-H
Primary DI / UDI-DI
05905817273188
Basic UDI-DI
5905817273SBHEQ
EMDN Code
W0202059085 Various processing instruments for hystology / cytology - consumables
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000050182

Other devices from OPTA-TECH Sp. z o.o.

See all devices from OPTA-TECH Sp. z o.o. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 05905817273188|5905817273SBHEQ 61 fields · synced 24 Oct 2026