Skip to content

091330-06

by Karl Storz SE & CO. KG

Ref 091330-06

091330-06 is a device classified as Class IIa in the EU and Class II in the US made by Karl Storz SE & CO. KG, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 4048551005431UE) and listed in FDA GUDID since 2 Mar 2020 (UDI-DI 04048551417331), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048551005431UE Basic UDI-DI 04048551417331UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551417331 UDI-DI Date2 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551005431UE registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 04048551417331 listed 2 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551417331
  2. Registered EUDAMED 4048551005431UE

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  • Withdrawn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
Flexible video otorhinolaryngoscope, single-use
Device name
Flexible endoscopes, sterile, single use
Model / reference
091330-06
Primary DI / UDI-DI
04048551417331
Basic UDI-DI
4048551005431UE
FDA product code
EOB
EMDN code
Z12021008 Rhinoscopes
GMDN term
Flexible video otorhinolaryngoscope, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4760
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 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.

Related devices

Category: Flexible video otorhinolaryngoscope, single-use

Similar devices in this category

Other devices filed under ENT ENDOSCOPY INSTRUMENTS.

Other devices from Karl Storz SE & CO. KG

See all devices from Karl Storz SE & CO. KG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)