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ZEISS Axio Observer 7

by Carl Zeiss Microscopy GmbH Germany EUDAMEDGUDID

Ref 431007-9904-000

Product code MTXEMDN W0202050303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04064897000082 UDI-DIDate28 Sep 2022ListedStatusListed
European UnionCE/IVDR EUDAMED Number4064897DEA002JP Basic UDI-DIDate8 Jul 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
ZEISS Axio Observer 7 EUDAMED
Zeiss Axio Observer GUDID
Generic Name
Inverted-stage light microscope
Device Name
Inverted Microscope
Model / Ref / Catalog
431007-9904-000, Axio Observer 7
Primary DI / UDI-DI
04064897000082
Basic UDI-DI
4064897DEA002JP
FDA Product Code
MTX
EMDN Code
W0202050303 Optical laboratory microscopes
GMDN Term
Inverted-stage light microscope
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
884.6190
Market of Registration
Germany
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
431007-9904-000
GUDID
Axio Observer 7
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000024424

Other devices from Carl Zeiss Microscopy GmbH

See all devices from Carl Zeiss Microscopy GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 7b195fff-683e-4452-9d03-cc5f8370f147 61 fields · synced 22 Oct 2026
  • FDA UDI 4d04e873-ce85-44cf-8480-8e6af1d6e5db 36 fields · synced 30 May 2026