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Lumolaser F9000321

by Asa SRL

Ref F9000321Model M

Lumolaser F9000321 is a device classified as Class IIb in the EU and Class II in the US made by Asa SRL, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 803376539MLSMHT) and listed in FDA GUDID since 16 May 2025 (UDI-DI 08033765391764), 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 Number803376539MLSMHT Basic UDI-DI 08033765391764UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033765391764 UDI-DI Date16 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 803376539MLSMHT registered 7 May 2026 Active
  • FDA GUDID UDI-DI 08033765391764 listed 16 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033765391764
  2. Registered EUDAMED 803376539MLSMHT

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  • Withdrawn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
Lumolaser
Generic name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / reference
F9000321, M
Primary DI / UDI-DI
08033765391764
Basic UDI-DI
803376539MLSMHT
FDA product code
ILY
EMDN code
Z120615 Therapeutic lasers
GMDN term
Musculoskeletal infrared phototherapy unit, non-wearable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5500
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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.

Related devices

Category: Musculoskeletal infrared phototherapy unit, non-wearable

Similar devices in this category

Other devices filed under THERAPEUTIC LASERS.

Other devices from Asa SRL

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)