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Fixer MI 2715

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref MI 2715Model INSTRUMENTS CLASS I

Fixer MI 2715 is a device classified as Class I in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI 999520000037K5) and listed in FDA GUDID since 26 Feb 2021 (UDI-DI 07899995210722), 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 Number999520000037K5 Basic UDI-DI 07899995210722UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995210722 UDI-DI Date26 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 999520000037K5 registered 12 Aug 2026 Active
  • FDA GUDID UDI-DI 07899995210722 listed 26 Feb 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899995210722
  2. Registered EUDAMED 999520000037K5

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  • Withdrawn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
Implant Mount HEX.2.7MM Long EUDAMED
Fixer GUDID
Generic name
Dental implant holding endpiece, reusable
Device name
Implant Mount
Model / Ref / Catalog
MI 2715, INSTRUMENTS CLASS I
Primary DI / UDI-DI
07899995210722
Basic UDI-DI
999520000037K5
FDA product code
NHA
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Dental implant holding endpiece, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental implant holding endpiece, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)