Skip to content

Xtreme

by Neatech.it

Ref S065

Xtreme (S065) is a Class I device made by Neatech.it, registered in EUDAMED on 18 Nov 2024 (Basic UDI-DI 805538493S065CR), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805538493S065CR Basic UDI-DI 08055384930353UDI-DIDate18 Nov 2024RegisteredStatusActive

Official records

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  • Withdrawn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

Model / reference
S065
Primary DI / UDI-DI
08055384930353
Basic UDI-DI
805538493S065CR
Direct marketing DI
08055384930353
EMDN code
Y122127 Electric wheelchairs
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000031601

Similar devices in this category

Other devices filed under ELECTRIC WHEELCHAIRS.

Other devices from Neatech.it

See all devices from Neatech.it →

Properties

Other properties (14, all answered No)