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Ms-39 103111

by Costruzioni Strumenti Oftalmici C.S.O. SRL

Ref 103111A00_001Model ASS. STRUMENTO OCT3 AXL

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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
European UnionCE/MDD EUDAMED NumberB-08056098473815 Basic UDI-DI 08056098473815UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056098473815 UDI-DI Date6 Oct 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ms-39
Generic Name
Ophthalmic spectral-domain optical coherence tomography system
Device Name
Ass. Strumento OCT3 Axl
Model / Reference
ASS. STRUMENTO OCT3 AXL EUDAMED
103111A00_001 EUDAMED
103111 GUDID
Primary DI / UDI-DI
08056098473815
Basic UDI-DI
B-08056098473815
510(k) Number
FDA Product Code
MXK
EMDN Code
Z12120121 Optical consistency tomographs
GMDN Term
Ophthalmic spectral-domain optical coherence tomography system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.1850
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ASS. STRUMENTO OCT3 AXL
103111A00_001
GUDID
103111
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Measuring Function
  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No