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Polaris 600 G16720

by Drägerwerk AG & Co. KGaA

Ref G16720Model 103024XK19Z000

Polaris 600 G16720 is a device classified as Class I in the EU and Class II in the US made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 040486751103024XK19Z00072) and listed in FDA GUDID since 3 Jun 2016 (UDI-DI 04048675416562), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number040486751103024XK19Z00072 Basic UDI-DI 04048675416562UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675416562 UDI-DI Date3 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 040486751103024XK19Z00072 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 04048675416562 listed 3 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048675416562
  2. Registered EUDAMED 040486751103024XK19Z00072

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  • Withdrawn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
Polaris 600 System EUDAMED
Polaris 600 GUDID
Generic name
Operating room light
Model / reference
G16720, 103024XK19Z000
Primary DI / UDI-DI
04048675416562
Basic UDI-DI
040486751103024XK19Z00072
Direct marketing DI
04048675416562
FDA product code
FTD
EMDN code
Z12010701, Z12010702
GMDN term
Operating room light
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4580
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Operating room light

Similar devices in this category

Other devices filed under GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS.

Other devices from Drägerwerk AG & Co. KGaA

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Properties

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