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Spotlight Access System

by Medos International SARL 64 variants

Part of a family of 64 devices: see the family page

Ref 282924570Model Spotlight Port Instruments

Spotlight Access System (282924570) is a device classified as Class IIa in the EU and Class II in the US made by Medos International SARL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0705034a002145R), cleared under FDA 510(k) K062814 on 15 Dec 2006 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10705034207469), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K062814

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002145R Basic UDI-DI 10705034207469UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034207469 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062814 Date15 Dec 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705034a002145R registered 22 Oct 2026 Active
  • FDA 510(k) K062814 decided 15 Dec 2006 Active
  • FDA GUDID UDI-DI 10705034207469 listed 30 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062814
  2. Listed FDA GUDID 10705034207469
  3. Registered EUDAMED 0705034a002145R

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Spotlight Access System EUDAMED
Spotlight GUDID
Generic name
Endoscopic light source unit, line-powered
Device name
Spotlight port, light source, line powered
Model / Ref / Catalog
Spotlight Port Instruments, 282924570
Primary DI / UDI-DI
10705034207469
Basic UDI-DI
0705034a002145R
Direct marketing DI
10705034207469
510(k) Number
FDA product code
GZT
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic light source unit, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4800
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Endoscopic light source unit, line-powered

Similar devices in this category

Other devices filed under LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)