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Singular 000957

by Conmed Corporation

Ref 000957

Singular 000957 is a device classified as Class IIb in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI B-10653405053163) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10653405053163), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10653405053163 Basic UDI-DI 10653405053163UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405053163 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10653405053163 registered 19 Jun 2026 Active
  • FDA GUDID UDI-DI 10653405053163 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10653405053163
  2. Registered EUDAMED B-10653405053163

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Singular
Generic name
Endoscopic electrosurgical electrode, monopolar, single-use
Device name
Endoscopic Surgical Instruments
Model / Ref / Catalog
000957
Primary DI / UDI-DI
10653405053163
Basic UDI-DI
B-10653405053163
FDA product code
KNS
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Endoscopic electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4300
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
Size
Length — 230 Centimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes
ImplantableEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 10653405053163: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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 electrosurgical electrode, monopolar, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)