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Druj-IS345

by Aptis Medical, LLC.

Ref DRUJ-IS345

Druj-IS345 is a device classified as Class IIb in the EU and Class II in the US made by Aptis Medical, LLC., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-B013DRUJIS3450) and listed in FDA GUDID since 27 Aug 2021 (UDI-DI B013DRUJIS3450), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B013DRUJIS3450 Basic UDI-DI B013DRUJIS3450UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB013DRUJIS3450 UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B013DRUJIS3450 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI B013DRUJIS3450 listed 27 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B013DRUJIS3450
  2. Registered EUDAMED B-B013DRUJIS3450

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  • Withdrawn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

Generic name
Wrist ulna-head prosthesis
Model / Ref / Catalog
DRUJ-IS345
Primary DI / UDI-DI
B013DRUJIS3450
Basic UDI-DI
B-B013DRUJIS3450
FDA product code
KXE
EMDN code
P09030402 Wrist prostheses ulnar components
GMDN term
Wrist ulna-head prosthesis
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3810
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI B013DRUJIS3450: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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: Wrist ulna-head prosthesis

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS.

Other devices from Aptis Medical, LLC.

See all devices from Aptis Medical, LLC. →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)