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Tissue-Tek® Paraform® LP Stacked Frames, White - Tissue-Tek® Paraform® LP Stacked Frames, White

by Sakura Finetek USA, Inc

Ref 7064Model Tissue-Tek® Paraform® Biopsy Cassettes, 13 x 13 mm

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 Number06152338265JL Basic UDI-DI 00615233008237UDI-DIDate9 Sep 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  • Withdrawn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
Tissue-Tek® Paraform® frames and cassettes
Model / Reference
Tissue-Tek® Paraform® Biopsy Cassettes, 13 x 13 mm, 7064
Primary DI / UDI-DI
00615233008237
Basic UDI-DI
06152338265JL
EMDN Code
W05030501 Inclusion devices, cassettes
Models / Variants
Tissue-Tek® Paraform® LP Stacked Frames, White
Device Class
Class A
EU 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