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Scheker DRUJ MITINT-100

by Aptis Medical, LLC.

Ref MITINT-100

Scheker DRUJ MITINT-100 is an instrument tray (EU MDD Class I; FDA Class I; FDA product code LRP, Tray, Surgical) made by Aptis Medical, LLC., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-B013MITINT1000) and listed in FDA GUDID since 26 Nov 2021 (UDI-DI B013MITINT1000), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B013MITINT1000 Basic UDI-DI B013MITINT1000UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB013MITINT1000 UDI-DI Date26 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B013MITINT1000 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI B013MITINT1000 listed 26 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B013MITINT1000
  2. Registered EUDAMED B-B013MITINT1000

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  • Withdrawn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
Scheker DRUJ
Generic name
Instrument tray, reusable
Model / Ref / Catalog
MITINT-100
Primary DI / UDI-DI
B013MITINT1000
Basic UDI-DI
B-B013MITINT1000
FDA product code
LRP
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Aptis Medical, LLC.

See all devices from Aptis Medical, LLC. →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)