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Planmeca Solanna

by Planmeca Oy

Ref 30009016

Planmeca Solanna (30009016) is a Class I device made by Planmeca Oy, registered in EUDAMED on 19 Oct 2021 (Basic UDI-DI 6430035420055M) and listed in FDA GUDID since 3 Jan 2018 (UDI-DI 06430035420544), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6430035420055M Basic UDI-DI 06430035420544UDI-DIDate19 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06430035420544 UDI-DI Date3 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 6430035420055M registered 19 Oct 2021 Active
  • FDA GUDID UDI-DI 06430035420544 listed 3 Jan 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06430035420544
  2. Registered EUDAMED 6430035420055M

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  • Withdrawn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

Generic name
LED dental light, line-powered
Model / Ref / Catalog
30009016, Solanna, 30006329
Primary DI / UDI-DI
06430035420544
Basic UDI-DI
6430035420055M
FDA product code
EAZ
EMDN code
Z12110180 Instruments for dental treatment units - hardware accessories
GMDN term
LED dental light, line-powered
Device class
Class I
Regulation number
872.4630
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30009016
GUDID
Solanna

Manufacturer details

EUDAMED SRN
FI-MF-000006499

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES.

Other devices from Planmeca Oy

See all devices from Planmeca Oy →

Properties

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