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StratoBlade

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

Ref SB-HPModel StratoBlade HP (SB-HP)

EMDN W0202059085

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5905817273SBHPAZ 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 23 Oct 2026

Device Name
Microtome Blades StratoBlade HP (SB-HP)
Model / Reference
StratoBlade HP (SB-HP), SB-HP
Primary DI / UDI-DI
05905817273195
Basic UDI-DI
5905817273SBHPAZ
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 210a15b7-5036-428e-8607-d2e0c39ae044 61 fields · synced 23 Oct 2026