Skip to content

Prostate Kit

by Leica Biosystems Richmond, Inc 3 variants

Part of a family of 25 devices: see the family page

Ref 3800854

Prostate Kit (3800854) is a device classified as Class A in the EU and Class I in the US made by Leica Biosystems Richmond, Inc, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 849832004UM) and listed in FDA GUDID since 12 Oct 2026 (UDI-DI 00849832023043), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00849832023043 UDI-DI Date12 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number849832004UM Basic UDI-DI 00849832023043UDI-DIDate8 Jun 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 849832004UM registered 8 Jun 2026 Active
  • FDA GUDID UDI-DI 00849832023043 listed 12 Oct 2026 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. Registered EUDAMED 849832004UM
  2. Listed FDA GUDID 00849832023043

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  • Withdrawn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
Prostate Kit EUDAMED
Leica Biosystems GUDID
Generic name
General tissue specimen container IVD, fixative/saline
Device name
Receptacles
Model / Ref / Catalog
3800854
Primary DI / UDI-DI
00849832023043
Basic UDI-DI
849832004UM
FDA product code
IFP
EMDN code
W0599 IVD general use consumable devices - other
GMDN term
General tissue specimen container IVD, fixative/saline
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
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.

Manufacturer details

EUDAMED SRN
US-MF-000014614
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under IVD GENERAL USE CONSUMABLE DEVICES - OTHER.

Other devices from Leica Biosystems Richmond, Inc

See all devices from Leica Biosystems Richmond, Inc →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)