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Round Bur R2RB30N

by Megagen Implant Co. Ltd

Ref R2RB30N

Round Bur R2RB30N is a device classified as Class IIa in the EU and Class I in the US made by Megagen Implant Co. Ltd, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 880972899174QE) and listed in FDA GUDID since 27 Feb 2025 (UDI-DI 08809985664687), 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 Number880972899174QE Basic UDI-DI 08809985664687UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809985664687 UDI-DI Date27 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880972899174QE registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 08809985664687 listed 27 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809985664687
  2. Registered EUDAMED 880972899174QE

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  • Withdrawn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

Trade name
Round Bur
Generic name
Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog
R2RB30N
Primary DI / UDI-DI
08809985664687
Basic UDI-DI
880972899174QE
FDA product code
NDP
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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: Fixture/appliance dental drill bit, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)