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ATMOS i View 21

by ATMOS MedizinTechnik GmbH & Co. KG

Ref 538.0000.0Model Microscopes

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04250365176155 UDI-DI Date27 Nov 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number42503651ENTiViewMikroK2 Basic UDI-DI 04250365176155UDI-DIDate8 Mar 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
ATMOS i View 21 EUDAMED
Atmos GUDID
Generic Name
ENT surgical microscope
Model / Reference
Microscopes EUDAMED
538.0000.0 EUDAMED
i View 21 GUDID
Primary DI / UDI-DI
04250365176155
Basic UDI-DI
42503651ENTiViewMikroK2
Direct Marketing DI
04250365176155
FDA Product Code
FSO
EMDN Code
Z12011101 Operative microscopes
GMDN Term
ENT surgical microscope
Device Class
Class I
Regulation Number
878.4700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Microscopes
538.0000.0
GUDID
i View 21

Manufacturer details

EUDAMED SRN
DE-MF-000005570

Other devices from ATMOS MedizinTechnik GmbH & Co. KG

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No