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ARveo 8

by Leica Microsystems (Schweiz) AG 2 variants

Ref 10449157Model ARveo 8

ARveo 8 (10449157) is a neurosurgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, surgical) made by Leica Microsystems (Schweiz) AG, registered in EUDAMED on 10 Nov 2025 (Basic UDI-DI 76308024ARveo8YT) and listed in FDA GUDID since 3 May 2024 (UDI-DI 07630802402622), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76308024ARveo8YT Basic UDI-DI 07630802402622UDI-DIDate10 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630802402622 UDI-DI Date3 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76308024ARveo8YT registered 10 Nov 2025 Active
  • FDA GUDID UDI-DI 07630802402622 listed 3 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630802402622
  2. Registered EUDAMED 76308024ARveo8YT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Neurosurgical microscope
Model / Ref / Catalog
ARveo 8, 10449157, 000000000010449157
Primary DI / UDI-DI
07630802402622
Basic UDI-DI
76308024ARveo8YT
FDA product code
EPT
EMDN code
Z12011101 Operative microscopes
GMDN term
Neurosurgical microscope
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ARveo 8
10449157
GUDID
000000000010449157

Manufacturer details

EUDAMED SRN
CH-MF-000021185
Authorised representative
Leica Microsystems CMS GmbH DE-AR-000021052

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Other devices filed under OPERATIVE MICROSCOPES.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)