Skip to content

Tissue-Tek® Cryo3® 5807

by Sakura Finetek USA, Inc

Ref 5807Model Tissue-Tek® Cryo3® Specimen Holders, Small

Tissue-Tek® Cryo3® 5807 is a device classified as Class A in the EU and Class I in the US made by Sakura Finetek USA, Inc, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 06152338267JQ) and listed in FDA GUDID since 14 Aug 2020 (UDI-DI 00615233079749), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number06152338267JQ Basic UDI-DI 00615233079749UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00615233079749 UDI-DI Date14 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 06152338267JQ registered 26 Aug 2026 Active
  • FDA GUDID UDI-DI 00615233079749 listed 14 Aug 2020 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00615233079749
  2. Registered EUDAMED 06152338267JQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Tissue-Tek® Cryo3® Specimen Holders, Small; 6 holders/pack EUDAMED
Tissue-Tek® Cryo3® GUDID
Generic name
Microscope slide coverslip IVD
Device name
Tissue-Tek® Cryo3® Specimen Holders
Model / Ref / Catalog
5807, Tissue-Tek® Cryo3® Specimen Holders, Small
Primary DI / UDI-DI
00615233079749
Basic UDI-DI
06152338267JQ
FDA product code
IDP
EMDN code
W02029085 Various hematology / histology / cytology instruments - consumables
GMDN term
Microscope slide coverslip IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3010
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Microscope slide coverslip IVD

Similar devices in this category

Other devices filed under VARIOUS HEMATOLOGY / HISTOLOGY /CYTOLOGY INSTRUMENTS.

Other devices from Sakura Finetek USA, Inc

See all devices from Sakura Finetek USA, Inc →

Properties

  • Single use
  • Professional testing
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)