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Invotec ENT Bur BC-70450P

by Invotec International, Inc.

Ref BC-70450PModel ENT Bur

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081850102ENTBursN5 Basic UDI-DI 00818501021512UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818501021512 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Invotec ENT Bur
Generic Name
Metal/carbide ENT bur, single-use
Device Name
ENT Bur
Model / Ref / Catalog
BC-70450P, ENT Bur
Description
CARBIDE BUR 4.5mm X 70mm, FLUTES: 10 PLAIN SHAFT
Primary DI / UDI-DI
00818501021512
Basic UDI-DI
081850102ENTBursN5
FDA Product Code
EQJ
EMDN Code
Q0399 ENT devices - other
GMDN Term
Metal/carbide ENT bur, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.4140
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Invotec International, Inc.

See all devices from Invotec International, Inc. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No