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M822 F20

by Leica Microsystems (Schweiz) AG

Ref 10448596Model M822

M822 F20 (10448596) is an ophthalmic surgical microscope (EU MDR Class I; FDA Class I; FDA product code FSO, Microscope, Surgical, General & Plastic Surgery) made by Leica Microsystems (Schweiz) AG, registered in EUDAMED on 11 Nov 2025 (Basic UDI-DI 76300035M822DL) and listed in FDA GUDID since 30 Jul 2021 (UDI-DI 07630003568752), 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 Number76300035M822DL Basic UDI-DI 07630003568752UDI-DIDate11 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630003568752 UDI-DI Date30 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300035M822DL registered 11 Nov 2025 Active
  • FDA GUDID UDI-DI 07630003568752 listed 30 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630003568752
  2. Registered EUDAMED 76300035M822DL

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  • Withdrawn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

Trade name
M822 F20 EUDAMED
M844 F20 / M822 F20 GUDID
Generic name
Ophthalmic surgical microscope
Device name
M822
Model / Ref / Catalog
M822, 10448596, 000000000010448596
Primary DI / UDI-DI
07630003568752
Basic UDI-DI
76300035M822DL
FDA product code
FSO
EMDN code
Z12011101 Operative microscopes
GMDN term
Ophthalmic 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
M822
10448596
GUDID
000000000010448596

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)