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DRSplus

by Centervue S.P.A.

Ref AXSDRME100

DRSplus (AXSDRME100) is an ophthalmic fundus camera (EU MDR Class IIa; FDA Class II; FDA product code MYC, Ophthalmoscope, Laser, Scanning) made by Centervue S.P.A., cleared under FDA 510(k) K213705 on 21 Dec 2021 (1 earlier submission), registered in EUDAMED on 26 Nov 2021 (Basic UDI-DI B-08053677040116) and listed in FDA GUDID since 9 Dec 2019 (UDI-DI 08053677040116), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213705↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK213705 Date21 Dec 2021IssuedStatusActive
European UnionCE/MDR EUDAMED NumberB-08053677040116 Basic UDI-DI 08053677040116UDI-DIDate26 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08053677040116 Basic UDI-DI 08053677040116UDI-DIDate26 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08053677040116 UDI-DI Date9 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K213705 decided 21 Dec 2021 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI B-08053677040116 registered 26 Nov 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08053677040116 listed 9 Dec 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K192113
  2. Listed FDA GUDID 08053677040116
  3. Registered EUDAMED B-08053677040116
  4. Cleared FDA 510(k) K213705

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Ophthalmic fundus camera
Model / reference
AXSDRME100 EUDAMED
DRSplus GUDID
Primary DI / UDI-DI
08053677040116
Basic UDI-DI
B-08053677040116, 805367704FundusCameraED
Direct marketing DI
08053677040116
FDA product code
MYC
EMDN code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
GMDN term
Ophthalmic fundus camera
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1570
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AXSDRME100
GUDID
DRSplus
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000017082

Similar devices in this category

Other devices filed under OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER.

Other devices from Centervue S.P.A.

See all devices from Centervue S.P.A. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)