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Conmed 00509108100

by Conmed Corporation

Ref 5091-081

Conmed 00509108100 (5091-081) is a device classified as Class IIa in the EU and Class I in the US made by Conmed Corporation, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI B-10845854002681) and listed in FDA GUDID since 6 Oct 2021 (UDI-DI 10845854002681), 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-10845854002681 Basic UDI-DI 10845854002681UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854002681 UDI-DI Date6 Oct 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10845854002681 registered 9 Apr 2026 Active
  • FDA GUDID UDI-DI 10845854002681 listed 6 Oct 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10845854002681
  2. Registered EUDAMED B-10845854002681

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  • Withdrawn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
Orthopaedic bur, single-use
Device name
Orthopedic, Non-active, Handpiece Bur
Model / Ref / Catalog
5091-081, 00509108100
Primary DI / UDI-DI
10845854002681
Basic UDI-DI
B-10845854002681
FDA product code
GFF
EMDN code
V0199 Cutting devices, single-use - other
GMDN term
Orthopaedic bur, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5091-081
GUDID
00509108100
Device classEUDAMED
Class IIa
GUDID
Class I
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 10845854002681: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bur, single-use

Similar devices in this category

Other devices filed under CUTTING DEVICES, SINGLE-USE - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)