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SET COMBI - otoscopio + lucciola

by Gima SpA

Ref 31300Model OTOSCOPI

SET COMBI - otoscopio + lucciola (31300) is a Class I device made by Gima SpA, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 8023279Z1214900600000002X), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8023279Z1214900600000002X Basic UDI-DI 08023279313000UDI-DIDate28 May 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 8023279Z1214900600000002X — open Devices and search for it

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Otoscopi
Model / reference
OTOSCOPI, 31300
Primary DI / UDI-DI
08023279313000
Basic UDI-DI
8023279Z1214900600000002X
Direct marketing DI
08023279313000
EMDN code
Z12149006 Direct outpatient otoscopes
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000011004

Similar devices in this category

Other devices filed under DIRECT OUTPATIENT OTOSCOPES.

Other devices from Gima SpA

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Properties

Other properties (14, all answered No)