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M320 W12

by Leica Microsystems (Schweiz) AG

Part of a family of 12 devices: see the family page

Ref 10448436Model M320

M320 W12 (10448436) is a general-purpose surgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Leica Microsystems (Schweiz) AG, registered in EUDAMED on 11 Nov 2025 (Basic UDI-DI 76300035M320CP) and listed in FDA GUDID since 23 Jun 2021 (UDI-DI 07630003559095), 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 Number76300035M320CP Basic UDI-DI 07630003559095UDI-DIDate11 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630003559095 UDI-DI Date23 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300035M320CP registered 11 Nov 2025 Active
  • FDA GUDID UDI-DI 07630003559095 listed 23 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630003559095
  2. Registered EUDAMED 76300035M320CP

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  • Withdrawn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
General-purpose surgical microscope
Device name
M320
Model / reference
M320 EUDAMED
10448436 EUDAMED
000000000010448436 GUDID
Primary DI / UDI-DI
07630003559095
Basic UDI-DI
76300035M320CP
FDA product code
EPT
EMDN code
Z12011101 Operative microscopes
GMDN term
General-purpose surgical 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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
M320
10448436
GUDID
000000000010448436

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)