Skip to content

Aesculap

by Aesculap AG 1,000+ variants

Ref ND017R

Aesculap (ND017R) is a Class I device made by Aesculap AG, registered in EUDAMED on 25 Sep 2025 (Basic UDI-DI 40392390000004842K) and listed in FDA GUDID since 21 Apr 2020 (UDI-DI 04038653109685), 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 Number40392390000004842K Basic UDI-DI 04038653109685UDI-DIDate25 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653109685 UDI-DI Date21 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000004842K registered 25 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653109685 listed 21 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653109685
  2. Registered EUDAMED 40392390000004842K

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  • Withdrawn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
THA instrument I
Model / Ref / Catalog
ND017R
Primary DI / UDI-DI
04038653109685
Basic UDI-DI
40392390000004842K
Direct marketing DI
04038653109685
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)