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TrueSpot collimated 2.0mm Handpiece

by Lumenis Be LTD

Ref AC-00013050Be

TrueSpot collimated 2.0mm Handpiece (AC-00013050Be) is a surgical laser system beam-focus handpiece (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lumenis Be Ltd, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI 729011777UPAHPH5) and listed in FDA GUDID since 4 Dec 2023 (UDI-DI 07290117771686), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011777UPAHPH5 Basic UDI-DI 07290117771686UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290117771686 UDI-DI Date4 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 729011777UPAHPH5 registered 9 Apr 2026 Active
  • FDA GUDID UDI-DI 07290117771686 listed 4 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290117771686
  2. Registered EUDAMED 729011777UPAHPH5

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TrueSpot collimated 2.0mm Handpiece EUDAMED
TrueSpot™ 2.0mm Handpiece GUDID
Generic name
Surgical laser system beam-focus handpiece
Model / reference
AC-00013050Be
Primary DI / UDI-DI
07290117771686
Basic UDI-DI
729011777UPAHPH5
FDA product code
GEX
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
GMDN term
Surgical laser system beam-focus handpiece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07290117771686: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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
IL-MF-000022063
Authorised representative
Lumenis (Germany) GmbH DE-AR-000007699

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Lumenis Be Ltd

See all devices from Lumenis Be Ltd →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)