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PicoStar

by Asclepion Laser Technologies GmbH 2 variants

Ref M16-9500-000

PicoStar (M16-9500-000) is a Class IIb device made by Asclepion Laser Technologies GmbH, registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI B-04058784001085), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04058784001085 Basic UDI-DI 04058784001085UDI-DIDate4 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
M16-9500-000
Primary DI / UDI-DI
04058784001085
Basic UDI-DI
B-04058784001085
EMDN code
Z12011017 Neodymium surgical laser
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005158

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Properties

Other properties (12, all answered No)