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Pen LED light

by Sapi Med SpA

Part of a family of 10 devices: see the family page

Ref B.0306

Pen LED light (B.0306) is a device classified as Class I in the EU and Class II in the US made by Sapi Med SpA, registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI 803363880CLDLGHTJ7) and listed in FDA GUDID since 2 Aug 2023 (UDI-DI 08033638801048), 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 Number803363880CLDLGHTJ7 Basic UDI-DI 08033638801048UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638801048 UDI-DI Date2 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 803363880CLDLGHTJ7 registered 5 Jun 2026 Active
  • FDA GUDID UDI-DI 08033638801048 listed 2 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033638801048
  2. Registered EUDAMED 803363880CLDLGHTJ7

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  • Withdrawn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
Pen-LED-Light EUDAMED
Pen LED GUDID
Generic name
Endoscopic light source unit, battery-powered
Device name
Light Generators Line
Model / Ref / Catalog
B.0306, Pen LED light
Primary DI / UDI-DI
08033638801048
Basic UDI-DI
803363880CLDLGHTJ7
FDA product code
NTN
EMDN code
Z129004 Light sources
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
B.0306
GUDID
Pen LED light
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: Endoscopic light source unit, battery-powered

Similar devices in this category

Other devices filed under LIGHT SOURCES.

Other devices from Sapi Med SpA

See all devices from Sapi Med SpA →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)