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Luer Rongeur forceps 411-548

by Efer Endoscopy

Part of a family of 80 devices: see the family page

Ref 411-548

Luer Rongeur forceps 411-548 is a device classified as Class I in the EU and Class II in the US made by Efer Endoscopy, registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI 404911311701R002001001WT), cleared under FDA 510(k) K854414 on 12 Mar 1986 and listed in FDA GUDID since 14 Nov 2023 (UDI-DI 04049113104973), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K854414

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number404911311701R002001001WT Basic UDI-DI 04049113104973UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049113104973 UDI-DI Date14 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK854414 Date12 Mar 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 404911311701R002001001WT registered 12 Jun 2026 Active
  • FDA 510(k) K854414 decided 12 Mar 1986 Active
  • FDA GUDID UDI-DI 04049113104973 listed 14 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K854414
  2. Listed FDA GUDID 04049113104973
  3. Registered EUDAMED 404911311701R002001001WT

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  • Withdrawn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
Luer Rongeur forceps
Generic name
Rigid optical bronchoscope
Device name
Rongeur/Trephine, Hohlmeißelzange/Trephine
Model / reference
411-548
Primary DI / UDI-DI
04049113104973
Basic UDI-DI
404911311701R002001001WT
Direct marketing DI
04049113104973
510(k) Number
FDA product code
EOQ
EMDN code
L091307 Orthopaedic surgery rongeurs, reusable
GMDN term
Rigid optical bronchoscope
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04049113104973: EUDAMED states No, FDA GUDID states Yes.

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: Rigid optical bronchoscope

Cleared under the same submission (K854414)

and 8 more cleared under K854414

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RONGEURS, REUSABLE.

Other devices from Efer Endoscopy

See all devices from Efer Endoscopy →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Reusable
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)