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Chrome

by Quanta System S.p.A. 2 variants

Ref PNMS00189Model Chrome

Chrome (PNMS00189) is a device classified as Class IIb in the EU and Class II in the US made by Quanta System S.p.A., registered in EUDAMED on 21 Jul 2025 (Basic UDI-DI B-08059173391806), cleared under FDA 510(k) K202503 on 18 Nov 2020 and listed in FDA GUDID since 22 Dec 2020 (UDI-DI 08059173391806), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202503

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08059173391806 Basic UDI-DI 08059173391806UDI-DIDate21 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08059173391806 UDI-DI Date22 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202503 Date18 Nov 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08059173391806 registered 21 Jul 2025 Active
  • FDA 510(k) K202503 decided 18 Nov 2020 Active
  • FDA GUDID UDI-DI 08059173391806 listed 22 Dec 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202503
  2. Listed FDA GUDID 08059173391806
  3. Registered EUDAMED B-08059173391806

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
Chrome, PNMS00189
Primary DI / UDI-DI
08059173391806
Basic UDI-DI
B-08059173391806
510(k) Number
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
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.

Manufacturer details

EUDAMED SRN
IT-MF-000007393

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)