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Wide Countersink Drill - Long Infapal

by Biotechnology Institute Sl

Ref INFAPAL

Wide Countersink Drill - Long Infapal is a device classified as Class IIa in the EU and Class I in the US made by Biotechnology Institute Sl, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-08435389804727) and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 08435389804727), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08435389804727 Basic UDI-DI 08435389804727UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435389804727 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08435389804727 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 08435389804727 listed 22 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08435389804727
  2. Registered EUDAMED B-08435389804727

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  • Withdrawn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
Wide Countersink Drill - Long
Generic name
Surgical countersink, reusable
Device name
Dental Drill - Countersink Drill
Model / reference
INFAPAL
Primary DI / UDI-DI
08435389804727
Basic UDI-DI
B-08435389804727
FDA product code
EJL
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Surgical countersink, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
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: Surgical countersink, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biotechnology Institute Sl

See all devices from Biotechnology Institute Sl →

Properties

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