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Leica Biosystems 39LP-300-5

by Leica Biosystems Richmond, Inc.

Ref 39LP-300-5

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number849832036V2 Basic UDI-DI 10849832028021UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10849832028021 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
LP Routine III Cassettes, Purple EUDAMED
Leica Biosystems GUDID
Generic Name
Histology tissue cassette IVD, laboratory processing, single-use
Device Name
Laser Cassettes
Model / Ref / Catalog
39LP-300-5
Primary DI / UDI-DI
10849832028021 EUDAMED
20849832028028 GUDID
Basic UDI-DI
849832036V2
Unit of Use DI
00849832028024
FDA Product Code
IDZ
EMDN Code
W0599 IVD general use consumable devices - other
GMDN Term
Histology tissue cassette IVD, laboratory processing, single-use
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3010
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10849832028021
GUDID
20849832028028
Device ClassEUDAMED
Class A
GUDID
Class I

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Contains Latex: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No