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Entree

by Conmed Corporation

Ref 7457

Entree (7457) is a Class I device made by Conmed Corporation, registered in EUDAMED on 11 Oct 2025 (Basic UDI-DI 084585408543DF), cleared under FDA 510(k) K850749 on 20 May 1985 and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 10845854013236), 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) K850749

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 Number084585408543DF Basic UDI-DI 10845854013236UDI-DIDate11 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854013236 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK850749 Date20 May 1985DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084585408543DF registered 11 Oct 2025 Active
  • FDA 510(k) K850749 decided 20 May 1985 Active
  • FDA GUDID UDI-DI 10845854013236 listed 24 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K850749
  2. Listed FDA GUDID 10845854013236
  3. Registered EUDAMED 084585408543DF

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  • Withdrawn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
Entree EUDAMED
Conmed GUDID
Generic name
Light source adaptor
Device name
Non-orthopedic, Active, Video Diagnosing/Monitoring, Light guide/Light guide fitting
Model / Ref / Catalog
7457
Primary DI / UDI-DI
10845854013236
Basic UDI-DI
084585408543DF
Direct marketing DI
20845854013233
510(k) Number
FDA product code
KQM
EMDN code
L0317 General surgery adapters and connectors, reusable
GMDN term
Light source adaptor
Device class
Class I
Regulation number
878.4160
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
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 10845854013236: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

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