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Quintex®

by Aesculap AG 35 variants

Ref SC428R

Quintex® (SC428R) is a Class I device made by Aesculap AG, registered in EUDAMED on 18 Nov 2025 (Basic UDI-DI 4039239000001160ZS) and listed in FDA GUDID since 17 Jun 2020 (UDI-DI 04046963711818), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4039239000001160ZS Basic UDI-DI 04046963711818UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963711818 UDI-DI Date17 Jun 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000001160ZS registered 18 Nov 2025 Active
  • FDA GUDID UDI-DI 04046963711818 listed 17 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963711818
  2. Registered EUDAMED 4039239000001160ZS

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  • Withdrawn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

Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
QUINTEX instrument Ir
Model / Ref / Catalog
SC428R
Primary DI / UDI-DI
04046963711818
Basic UDI-DI
4039239000001160ZS
Direct marketing DI
04046963711818
FDA product code
LRY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Similar devices in this category

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

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)