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MEDENTiKA 0-32-08

by MEDENTiKA GmbH

Part of a family of 27 devices: see the family page

Ref 0-32-08Model MedentiGuide sleeves

MEDENTiKA 0-32-08 is a device classified as Class IIa in the EU and Class I in the US made by MEDENTiKA GmbH, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI 42515748MED006AB) and listed in FDA GUDID since 8 Apr 2020 (UDI-DI 04251574801388), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42515748MED006AB Basic UDI-DI 04251574801388UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04251574801388 UDI-DI Date8 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42515748MED006AB registered 29 Jul 2026 Active
  • FDA GUDID UDI-DI 04251574801388 listed 8 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04251574801388
  2. Registered EUDAMED 42515748MED006AB

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  • Withdrawn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
MEDENTiKA
Generic name
Surgical drill guide, single-use
Model / Ref / Catalog
0-32-08, MedentiGuide sleeves
Primary DI / UDI-DI
04251574801388 EUDAMED
EMKA032089 GUDID
Basic UDI-DI
42515748MED006AB
FDA product code
NDP
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Surgical drill guide, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04251574801388
GUDID
EMKA032089
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 04251574801388; FDA GUDID lists EMKA032089), 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: Surgical drill guide, single-use

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from MEDENTiKA GmbH

See all devices from MEDENTiKA GmbH →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)