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1.2/1.5 Countersink f Cort.Screws, Dental

by Medartis AG

Ref A-3310, A-3310S

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76308948012UU Basic UDI-DI Date27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037865155 UDI-DI Date24 Feb 2023ListedStatusListed 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  • Withdrawn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
1.2/1.5 Countersink f Cort.Screws,Dental EUDAMED
Aptus GUDID
Generic Name
Orthopaedic bur, reusable
Device Name
Countersinks (sterile, non-sterile)
Rotating and cutting instruments (connected to an active device)
Model / Ref / Catalog
A-3310, A-3310S
Primary DI / UDI-DI
07630037865155, 07630037865162
Basic UDI-DI
76308948012UU, 76300378015PD
FDA Product Code
HTW
EMDN Code
Z12130503 Orthopaedic surgical drills
GMDN Term
Orthopaedic bur, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
No
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CH-MF-000022291
Authorised representative
Medartis GmbH DE-AR-000005810

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Single Use: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No