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PROVEO 8x

by Leica Microsystems (Schweiz) AG

Ref 10449172Model PROVEO 8x

PROVEO 8x (10449172) is an ophthalmic surgical microscope (EU MDR Class IIa; FDA Class I; FDA product code HRM, Microscope, Operating & Accessories, Ac-Powered, Ophthalmic) made by Leica Microsystems (Schweiz) AG, registered in EUDAMED on 11 Nov 2025 (Basic UDI-DI 76308024PROVEO8xEQ) and listed in FDA GUDID since 3 Oct 2025 (UDI-DI 07630802403711), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76308024PROVEO8xEQ Basic UDI-DI 07630802403711UDI-DIDate11 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630802403711 UDI-DI Date3 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76308024PROVEO8xEQ registered 11 Nov 2025 Active
  • FDA GUDID UDI-DI 07630802403711 listed 3 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630802403711
  2. Registered EUDAMED 76308024PROVEO8xEQ

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  • Withdrawn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
Ophthalmic surgical microscope
Model / Ref / Catalog
PROVEO 8x, 10449172
Primary DI / UDI-DI
07630802403711
Basic UDI-DI
76308024PROVEO8xEQ
FDA product code
HRM
EMDN code
Z12011101 Operative microscopes
GMDN term
Ophthalmic surgical microscope
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa 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
CH-MF-000021185
Authorised representative
Leica Microsystems CMS GmbH DE-AR-000021052

Similar devices in this category

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)