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5820025140

by Stryker Corp.

Ref 5820-025-140Model 08858251002018S5

5820025140 (5820-025-140) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 3 Oct 2026 (Basic UDI-DI 08858251002018S5) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613252706595), active as of 23 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number08858251002018S5 Basic UDI-DI 07613252706595UDI-DIDate3 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252706595 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002018S5 registered 3 Oct 2026 Active
  • FDA GUDID UDI-DI 07613252706595 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252706595
  2. Registered EUDAMED 08858251002018S5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Diamond ENT bur, single-use
Device name
Coarse Diamond Egg Bur
Model / Ref / Catalog
08858251002018S5, 5820-025-140, 5820025140
Primary DI / UDI-DI
07613252706595
Basic UDI-DI
08858251002018S5
FDA product code
HBE
EMDN code
V0199 Cutting devices, single-use - other
GMDN term
Diamond ENT bur, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002018S5
5820-025-140
GUDID
5820025140
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Diamond ENT bur, single-use

Similar devices in this category

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

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)