Skip to content

Hopkins 27035BA

by Karl Storz SE & CO. KG

Ref 27035BA

Hopkins 27035BA 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 19 May 2026 (Basic UDI-DI 4048551000546TV) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04048551232460), 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 Number4048551000546TV Basic UDI-DI 04048551232460UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551232460 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000546TV registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551232460 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551232460
  2. Registered EUDAMED 4048551000546TV

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  • Withdrawn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
Hopkins
Generic name
Rigid optical cystourethroscope
Device name
Compact telescopes, suction/irrigation
Model / reference
27035BA
Primary DI / UDI-DI
04048551232460
Basic UDI-DI
4048551000546TV
FDA product code
FAJ
EMDN code
Z12020702 Cystourethroscopes
GMDN term
Rigid optical cystourethroscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
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: Rigid optical cystourethroscope

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

Other devices from Karl Storz SE & CO. KG

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

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)