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Tissue-Tek® Paraform® LP Stacked Frames, Yellow;400 stacked frames/box

by Sakura Finetek USA, Inc EUDAMED

Active European Union

Ref 7065Model Tissue-Tek® Paraform® Biopsy Cassettes, 13 x 13 mm

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number06152338265JL Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Tissue-Tek® Paraform® frames and cassettes
Model / Reference
Tissue-Tek® Paraform® Biopsy Cassettes, 13 x 13 mm, 7065
Primary DI / UDI-DI
00615233008244
Basic UDI-DI
06152338265JL
EMDN Code
W05030501 Inclusion devices, cassettes
Models / Variants
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000022208
Authorised representative
Sakura Finetek Europe B.V. NL-AR-000007853

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Properties

  • Professional Testing

Other properties (10)

  • 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
  • New Device: No