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Leica Biosystems 3801733

by Leica Biosystems Richmond, Inc.

Ref 3801733

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00849832015581 UDI-DI Date12 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number849832029V5 Basic UDI-DI 00849832015581UDI-DIDate24 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
HistoCore SPECTRA CV X1 Mounting Media EUDAMED
Leica Biosystems GUDID
Generic Name
Microscopy mounting medium IVD
Device Name
Spectra
Model / Ref / Catalog
3801733
Primary DI / UDI-DI
00849832015581 EUDAMED
10849832015588 GUDID
Basic UDI-DI
849832029V5
Direct Marketing DI
00849832015581
FDA Product Code
KEQ
EMDN Code
W0599 IVD general use consumable devices - other
GMDN Term
Microscopy mounting medium IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00849832015581
GUDID
10849832015588
Device ClassEUDAMED
Class A
GUDID
Class I

Other devices from Leica Biosystems Richmond, Inc.

See all devices from Leica Biosystems Richmond, Inc. →

Properties

  • Reagent
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No