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Surgical Instrument Mart 01

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

Ref MART 01Model INSTRUMENTS CLASS I

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 Number999520000031JR Basic UDI-DI 07899995296320UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995296320 UDI-DI Date10 Mar 2021ListedStatusListed 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  • Withdrawn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
Surgical Mallet EUDAMED
Surgical Instrument GUDID
Generic Name
Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog
MART 01, INSTRUMENTS CLASS I
Primary DI / UDI-DI
07899995296320
Basic UDI-DI
999520000031JR
FDA Product Code
KCT
EMDN Code
L159099 Odontostomatology instruments, reusable - other
GMDN Term
Fixture/appliance dental drill bit, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Fixture/appliance dental drill bit, reusable

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

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Properties

  • Reusable
  • Reprocessed
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Expiration Date: No