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Diego Elite SB4015SC

by Gyrus Acmi, Inc.

Ref SB4015SC

Diego Elite SB4015SC is a device classified as Class IIa in the EU and Class I in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-00821925035522) and listed in FDA GUDID since 14 Sep 2018 (UDI-DI 00821925035522), 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-00821925035522 Basic UDI-DI 00821925035522UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925035522 UDI-DI Date14 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00821925035522 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00821925035522 listed 14 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821925035522
  2. Registered EUDAMED B-00821925035522

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  • Withdrawn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
Diego Elite
Generic name
Metal/carbide ENT bur, single-use
Device name
SB4015SC
Model / reference
SB4015SC
Primary DI / UDI-DI
00821925035522 EUDAMED
00821925041295 GUDID
Basic UDI-DI
B-00821925035522
FDA product code
EQJ
EMDN code
Q030302 ENT surgery burs and handpieces, single-use
GMDN term
Metal/carbide ENT bur, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.4140
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925035522
GUDID
00821925041295
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925035522; FDA GUDID lists 00821925041295), so their flags are not compared. 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: Metal/carbide ENT bur, single-use

Similar devices in this category

Other devices filed under ENT SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)