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Extra 818

by Active Optical Systems Ltd

Ref 818

Extra 818 is a medical device (EU MDR Class I) made by Active Optical Systems Ltd, registered in EUDAMED on 22 Aug 2022 (Basic UDI-DI 7290016727IPLC3Z), 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 Number7290016727IPLC3Z Basic UDI-DI 07290016727128UDI-DIDate22 Aug 2022RegisteredStatusActive

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  • Withdrawn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

Device name
Extra
Model / reference
818
Primary DI / UDI-DI
07290016727128
Basic UDI-DI
7290016727IPLC3Z
Direct marketing DI
07290016727128
EMDN code
Z12040201, Z12040202
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000024754
Authorised representative
QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665

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Properties

Other properties (14, all answered No)