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Conmed 130316-15NS

by Conmed Corporation

Ref 130316-15NS

Conmed 130316-15NS is a device classified as Class IIb in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI B-10653405033073) and listed in FDA GUDID since 30 Nov 2020 (UDI-DI 10653405033073), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10653405033073 Basic UDI-DI 10653405033073UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405033073 UDI-DI Date30 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10653405033073 registered 14 Apr 2026 Active
  • FDA GUDID UDI-DI 10653405033073 listed 30 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10653405033073
  2. Registered EUDAMED B-10653405033073

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  • Withdrawn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
Conmed
Generic name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device name
Non-orthopedic, Active, Instrument, Electrosurgical, Pencil, Reusable
Model / Ref / Catalog
130316-15NS
Primary DI / UDI-DI
10653405033073
Basic UDI-DI
B-10653405033073
FDA product code
GEI
EMDN code
L180301 Open electrosurgery handpieces, reusable
GMDN term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
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 10653405033073: EUDAMED states Yes, FDA GUDID states No.

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: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY HANDPIECES, REUSABLE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

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